## Protocol Section
### Identification Module
**NCT ID:** NCT06435975

**Brief Title:** Physical Activity in Rectal Cancer Survivors

**Official Title:** Pilot Study of Physical Activity Intervention to Manage Bowel Dysfunction in Rectal Cancer Survivors

#### Organization Study ID Info
**ID:** UPCC 20221
#### Organization
**Class:** OTHER
**Full Name:** Abramson Cancer Center at Penn Medicine
#### Secondary ID Infos
**Domain:** Abramson Cancer Center of the University of Pennsylvania
**ID:** 849585
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-03-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-03-06

**Type:** ACTUAL

#### Start Date
**Date:** 2022-06-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Abramson Cancer Center at Penn Medicine

#### Responsible Party

**Investigator Affiliation:** Abramson Cancer Center at Penn Medicine

**Investigator Full Name:** Erica Pettke, MD, MPH, FACS

**Investigator Title:** Physician

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The goal of this clinical trial is to test a telehealth-based personalized physical activity intervention in adult patients diagnosed with Stage I-III rectal cancer. The main question it aims to answer are how to better understand the experiences of rectal cancer survivors who are coping with bowel dysfunction and how physical activity can improve their quality of life.

Participants will be asked to:

1. Complete surveys to assess bowel function and quality of life
2. Participate in 12 Telehealth Sessions (one session a week) to discuss and review bowel dysfunction
3. Perform daily physical activity

**Detailed Description:** The goal of this clinical trial is to administer and determine the feasibility of a personalized physical activity intervention for rectal cancer survivors. Structured physical activity interventions will be administered over a three-month period. An exit interview will be conducted at the completion of this time period.

### Conditions Module

**Conditions:**

- Rectal Cancer

- Rectosigmoid Cancer

**Keywords:**

- Rectal Cancer

- Physical Activity

- Bowel Dysfunction

- Telehealth

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants in this arm will be asked to complete a series of surveys, participate in telehealth-based interventions, and engage in moderate physical activity.

**Intervention Names:**

- Other: Physical Activity

- Other: Survey

- Behavioral: Telehealth Lifestyle Coaching

**Label:** Experimental

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental

**Description:** Participants will perform a baseline +4000 steps/day for the duration of the study. Aerobic exercise, similar to a brisk walk, will be recommended as the primary mode of exercise.

**Name:** Physical Activity

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Experimental

**Description:** Participants will complete a series of survey at multiple points throughout this study to assess quality of life issues. Questionnaires may be completed via paper forms with prepaid postage envelopes or using a REDCap online survey.

**Name:** Survey

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Experimental

**Description:** Participants will meet with a health coach, the Principal Investigator, to review baseline bowel habits and symptoms as well as discuss physical activity and potential strategies to achieve this goal, on a weekly basis for 12 weeks.

**Name:** Telehealth Lifestyle Coaching

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Administer and determine the feasibility of a PA intervention. We will administer a telehealth physical activity intervention to 20 RC survivors (10 males and 10 females, at least 10 of which will be racial and/or ethnic minorities) over 12 weeks. Feasibility of the intervention will be measured by the percentage of participants who agree to participate of the total approached as well as completion of the intervention which will be defined as completion of ≥80% of the intervention (telehealth calls).

**Measure:** Feasibility of Physical Activity Intervention

**Time Frame:** From enrollment to the end of treatment at 12 weeks.

#### Secondary Outcomes

**Description:** Using qualitative methods, evaluate the acceptability of and satisfaction with the intervention as reported by survivors. After completion of the intervention or decision to discontinue participation, we will administer a semi-structured exit interview to evaluate the acceptability of the intervention.

**Measure:** Acceptability and Participant Satisfaction with Physical Activity Intervention

**Time Frame:** From enrollment to the end of treatment after 12 weeks.

**Description:** Using the Memorial Sloan Kettering bowel function instrument administered pre-post PA intervention, describe the change in total bowel symptom score in the pilot cohort.

**Measure:** Evaluation using Memorial Sloan Kettering Cancer Center Bowel Function Instrument Scale to describe the change in total bowel symptom score in the pilot cohort from minimum score of 13 to maximum score of 65, where the higher score is the better outcome.

**Time Frame:** At 0 weeks, 3 weeks, and 6 months after completion of the initial intervention.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Diagnosis of Stage I-III cancers of the rectum/rectosigmoid.
2. Age 18 or older
3. Three months to 5 years post-treatment completion
4. Have a rectal or anal anastomosis with a LARS score of 21-42
5. At least 10 participants must be racial/ethnic minority (Black/African American, Hispanic/Latino)
6. Ability to be physically active and cleared by MD
7. Patients must be able to read and understand English.
8. Participants must sign the informed consent form

The study is open to anyone regardless of gender or ethnicity. Efforts will be made to extend the accrual to a representative population, but in a trial which will accrue 20 subjects, a balance must be struck between subject safety considerations and limitations on the number of individuals exposed to potentially toxic or ineffective treatments on the one hand and the need to explore gender, racial, and ethnic aspects of clinical research on the other. If differences in outcome that correlate to gender, racial, or ethnic identity are noted, accrual may be expanded, or additional studies may be performed to investigate those differences more fully.

Exclusion Criteria:

1. Patients failing to meet all the above inclusion criteria will be excluded from the study.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Philadelphia

**Country:** United States

**Facility:** Hospital of the University of Pennsylvania

**State:** Pennsylvania

**Zip:** 19104

#### Overall Officials

**Official 1:**

**Affiliation:** University of Pennsylvania

**Name:** Erica Pettke, MD, MPH, FACS

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

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**PMID:** 16041212

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#### See Also Links

**Label:** American Cancer Society. Cancer Facts \& Figures 2020

**URL:** https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html

**Label:** 2018 Physical Activity Guidelines for Americans. US Department of Health and Human Services; 2008

**URL:** https://health.gov/sites/default/files/2019-09/Physical_Activity_Guidelines_2nd_edition.pdf

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000015179

- Term: Colorectal Neoplasms

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000012002

- Term: Rectal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

### Condition Browse Module - Browse Leaves

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14846

- Name: Rectal Neoplasms

- Relevance: HIGH

- As Found: Rectal Cancer

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M10448

- Name: Intestinal Neoplasms

- 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: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012004

- Term: Rectal Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
