## Protocol Section
### Identification Module
**NCT ID:** NCT05501379

**Acronym:** OncoPhys

**Brief Title:** Comparison of the Physical Activity in Cancer Patients Assessed by Questionnaire and Motion Tracker

**Official Title:** Comparison of the Physical Activity Assessed by an Accelerometer and the International Physical Activity Questionnaire in Oncologic Patients

#### Organization Study ID Info
**ID:** BB 067/22
#### Organization
**Class:** OTHER
**Full Name:** University Medicine Greifswald
### Status Module
#### Completion Date
**Date:** 2024-10

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-09

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-08

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-09-21

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2022-08-15
**Type:** ACTUAL
**Study First Submit Date:** 2022-08-11
**Study First Submit QC Date:** 2022-08-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Medicine Greifswald

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Physical activity is an important aspect of cancer therapy but correct measurement of physical activity is difficult. In this study, the physical activity of patients undergoing cancer therapy is assessed by questionnaire and by motion tracker. The results are then compared to answer whether there are differences between the two measurements. Findings of this study will help to improve the assessment of physical activity in cancer patients.

**Detailed Description:** Although physical activity has been identified as a relevant determinant of cancer therapy outcome, its valid assessment remains challenging. In principle, direct and indirect assessment instruments can be employed for assessment of physical activity. While direct instruments, e.g. accelerometers, are considered to provide a more objective measurement, indirect tools such as questionnaires are less expensive and more applicable for use in larger study populations. The validity of both forms of measurements in cancer patients is however not well studied. Therefore, this study aims to elucidate the relative validity of an accelerometer in comparison to a standardized physical questionnaire at different time points of cancer therapy. Findings of this study will allow conclusions regarding the ideal modalities for assessment of physical activity in cancer patients.

### Conditions Module

**Conditions:**

- Lymphoma

- Pancreas Cancer

- Colorectal Cancer

**Keywords:**

- Physical Activity

- Accelerometer

- International Physical Activity Questionnaire

- Cancer Therapy

- GeneActiv

- Quality of Life

- Fatigue

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with a verified diagnosis of lymphoma, colorectal or pancreatic cancer requiring surgical, chemo or radio therapy.

**Intervention Names:**

- Other: No intervention - observational study only

**Label:** Cancer Patients

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cancer Patients

**Description:** No intervention - observational study only

**Name:** No intervention - observational study only

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Difference in physical activity measured by the GeneActiv accelerometer and the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs)

**Measure:** Comparison of physical activity assessments within 1 week after initiation of cancer therapy

**Time Frame:** 1 week after initiation of cancer therapy

#### Secondary Outcomes

**Description:** Difference in physical activity measured by the GeneActiv accelerometer and the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs)

**Measure:** Comparison of physical activity assessments 12 weeks after initiation of cancer therapy

**Time Frame:** 12 weeks after initiation of cancer therapy

**Description:** Difference in changes of physical activity measured by the GeneActiv accelerometer and the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs)

**Measure:** Comparison of changes in physical activity between assessements within 1 week and 12 weeks after initiation of cancer therapy

**Time Frame:** 12 weeks after initiation of cancer therapy

**Description:** Physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs)

**Measure:** Physical activity assessed by accelerometer

**Time Frame:** 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy

**Description:** Physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs)

**Measure:** Physical activity assessed by questionnaire

**Time Frame:** 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy

**Description:** Association between ECOG Performance Status and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs)

**Measure:** Relation of Eastern Co-operative Oncology Group (ECOG) Performance Status to physical activity assessed by accelerometer

**Time Frame:** 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy

**Description:** Association between ECOG Performance Status and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs)

**Measure:** Relation of Eastern Co-operative Oncology Group (ECOG) Performance Status to physical activity assessed by questionnaire

**Time Frame:** 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy

**Description:** Association between KPS and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs)

**Measure:** Relation of Karnofsky Performance Status (KPS) to physical activity assessed by accelerometer

**Time Frame:** 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy

**Description:** Association between KPS and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs)

**Measure:** Relation of Karnofsky Performance Status (KPS) to physical activity assessed by questionnaire

**Time Frame:** 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy

**Description:** Association between age and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs)

**Measure:** Relation of age to physical activity assessed by accelerometer

**Time Frame:** 1 week after initiation of cancer therapy

**Description:** Association between age and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs)

**Measure:** Relation of age to physical activity assessed by questionnaire

**Time Frame:** 1 week after initiation of cancer therapy

**Description:** Association between sex and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs)

**Measure:** Relation of sex to physical activity assessed by accelerometer

**Time Frame:** 1 week after initiation of cancer therapy

**Description:** Association between sex and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs)

**Measure:** Relation of sex to physical activity assessed by questionnaire

**Time Frame:** 1 week after initiation of cancer therapy

**Description:** Association between quality of life assessed by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ C-30) and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs)

**Measure:** Relation of quality of life to physical activity assessed by accelerometer

**Time Frame:** 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy

**Description:** Association between quality of life assessed by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ C-30) and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs)

**Measure:** Relation of quality of life to physical activity assessed by questionnaire

**Time Frame:** 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy

**Description:** Association between quality of life assessed by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ C-30) and cancer therapy modality

**Measure:** Therapy-related quality of life

**Time Frame:** 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy

**Description:** Association between fatigue assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire (EORTC QLQFA-12) and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs)

**Measure:** Relation of fatigue to physical activity assessed by accelerometer

**Time Frame:** 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy

**Description:** Association between fatigue assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire (EORTC QLQFA-12) and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs)

**Measure:** Relation of fatigue to physical activity assessed by questionnaire

**Time Frame:** 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy

**Description:** Association between fatigue assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire (EORTC QLQFA-12) and cancer therapy modality

**Measure:** Therapy-related fatigue

**Time Frame:** 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy

**Description:** Association between sleep duration measured by the GeneActiv accelerometer in hours and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs)

**Measure:** Relation of sleep duration to physical activity assessed by accelerometer

**Time Frame:** 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy

**Description:** Association between sleep duration measured by the GeneActiv accelerometer in hours and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs)

**Measure:** Relation of sleep duration to physical activity assessed by questionnaire

**Time Frame:** 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy

**Description:** Association between sleep efficiency, i.e. the ratio of sleep duration to total bed time measured by the GeneActiv accelerometer in hours, and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs)

**Measure:** Relation of sleep efficiency to physical activity assessed by accelerometer

**Time Frame:** 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy

**Description:** Association between sleep efficiency, i.e. the ratio of sleep duration to total bed time measured by the GeneActiv accelerometer in hours, and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs)

**Measure:** Relation of sleep efficiency to physical activity assessed by questionnaire

**Time Frame:** 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy

**Description:** Association between sleep duration measured by the GeneActiv accelerometer in hours and cancer therapy modality

**Measure:** Therapy-related sleep duration

**Time Frame:** 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy

**Description:** Association between sleep efficiency, i.e. the ratio of sleep duration to total bed time measured by the GeneActiv accelerometer in hours, and cancer therapy modality

**Measure:** Therapy-related sleep efficiency

**Time Frame:** 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy

**Description:** Differences in fatigue assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire (EORTC QLQFA-12)

**Measure:** Changes in fatigue between assessements before and 12 weeks after initiation of cancer therapy

**Time Frame:** 12 weeks after initiation of cancer therapy

**Description:** Differences in quality of life assessed by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ C-30)

**Measure:** Changes in quality of life between assessements before and 12 weeks after initiation of cancer therapy

**Time Frame:** 12 weeks after initiation of cancer therapy

**Description:** Association between tumor entity and changes in physical activity measured by the GeneActiv accelerometer and the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs)

**Measure:** Relation of tumor entity to changes in physical activity between assessements within 1 week and 12 weeks after initiation of cancer therapy

**Time Frame:** 12 weeks after initiation of cancer therapy

**Description:** Association between cancer therapy modality and changes in physical activity measured by the GeneActiv accelerometer and the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs)

**Measure:** Relation of cancer therapy modality to changes in physical activity between assessements within 1 week and 12 weeks after initiation of cancer therapy

**Time Frame:** 12 weeks after initiation of cancer therapy

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* verified diagnosis of lymphoma, colorectal or pancreatic cancer
* requirement of surgical, chemo or radio therapy
* provision of informed consent

Exclusion Criteria:

* pregnancy
* inability to provide consent
* use of a rollator

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients will be recruited at University Medicine Greifswald (Northeast Germany). Patients with the verified diagnosis of lymphoma, colerectal or pancreatic cancer requiring surgical, chemo or radio therapy will be identified in the respective wards or day care units of the hosptial.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ali.aghdassi@med.uni-greifswald.de

**Name:** Ali A Aghdassi, Professor

**Phone:** +493834867230

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Greifswald

**Contacts:**

***Contact 1:***

- **Email:** ali.aghdassi@med.uni-greifswald.de

- **Name:** Ali A Aghdassi, Professor

- **Phone:** +493834867230

- **Role:** CONTACT

***Contact 2:***

- **Name:** Ali A Aghdassi, Professor

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Mats L Wiese, MSc

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Sebastian Schmidt

- **Role:** SUB_INVESTIGATOR

**Country:** Germany

**Facility:** University Medicine Greifswald

**Status:** RECRUITING

**Zip:** 17475

#### Overall Officials

**Official 1:**

**Affiliation:** University Medicine Greifswald

**Name:** Ali A Aghdassi, Professor

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000010182

- Term: Pancreatic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13110

- Name: Pancreatic Neoplasms

- Relevance: HIGH

- As Found: Pancreas Cancer

- ID: M11220

- Name: Lymphoma

- Relevance: LOW

- As Found: Unknown

- ID: M8364

- Name: Fatigue

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M13102

- Name: Pancreatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

- ID: T4387

- Name: Pancreatic Cancer

- Relevance: LOW

- As Found: Unknown

- ID: T3543

- Name: Lymphosarcoma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010190

- Term: Pancreatic Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
