## Protocol Section
### Identification Module
**NCT ID:** NCT03902379

**Brief Title:** Web-Based Coping and Communication Skills Intervention in Improving Psychological Adaptation in Patients With Gynecological Cancer

**Official Title:** Web-Based Coping and Communication Skills Intervention for Women Who Are Newly Diagnosed With Gynecological Cancer: A Pilot Study

#### Organization Study ID Info
**ID:** Pro20160000637
#### Organization
**Class:** OTHER
**Full Name:** Rutgers, The State University of New Jersey
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2017-02300
**Type:** REGISTRY
**ID:** Pro20160000637
**Domain:** Rutgers Cancer Institute of New Jersey
**ID:** 131602
**Type:** OTHER
**ID:** P30CA072720
**Link:** https://reporter.nih.gov/quickSearch/P30CA072720
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2020-05-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-04-19

**Type:** ACTUAL

**Last Update Submit Date:** 2021-04-16

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2020-05-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2016-07-27

**Type:** ACTUAL

**Status Verified Date:** 2021-04

#### Study First Post Date
**Date:** 2019-04-04
**Type:** ACTUAL
**Study First Submit Date:** 2018-07-06
**Study First Submit QC Date:** 2019-04-01
**Why Stopped:** The study was never initiated, no patients were enrolled. It has been closed with the IRB.
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** OTHER

**Name:** Rutgers, The State University of New Jersey

#### Responsible Party

**Investigator Affiliation:** Rutgers Cancer Institute of New Jersey

**Investigator Full Name:** Sharon Manne, PhD

**Investigator Title:** Professor of Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This pilot clinical trial studies how well web-based coping and communication skills intervention works in improving psychological adaptation in patients with gynecological cancer. Web-based intervention, such as coping and communication skills intervention, may help doctors to get a better understanding of ways to help gynecological cancer patients cope with their cancer experience.

**Detailed Description:** PRIMARY OBJECTIVES:

I. To examine the feasibility and acceptability of an online coping and communication skills intervention (CCI).

II. To collect pilot data on the impact of online CCI on global and cancer-specific distress.

OUTLINE:

Patients complete 3 modules of online CCI intervention.

After completion of study, patients are followed up at 2 months.

### Conditions Module

**Conditions:**

- Endometrial Carcinoma

- Stage 0 Fallopian Tube Cancer AJCC v7

- Stage I Fallopian Tube Cancer AJCC v6 and v7

- Stage I Ovarian Cancer AJCC v6 and v7

- Stage IA Fallopian Tube Cancer AJCC v6 and v7

- Stage IA Ovarian Cancer AJCC v6 and v7

- Stage IB Fallopian Tube Cancer AJCC v6 and v7

- Stage IB Ovarian Cancer AJCC v6 and v7

- Stage IC Fallopian Tube Cancer AJCC v6 and v7

- Stage IC Ovarian Cancer AJCC v6 and v7

- Stage II Cervical Cancer AJCC v7

- Stage II Fallopian Tube Cancer AJCC v6 and v7

- Stage II Ovarian Cancer AJCC v6 and v7

- Stage II Uterine Corpus Cancer AJCC v7

- Stage IIA Cervical Cancer AJCC v7

- Stage IIA Fallopian Tube Cancer AJCC v6 and v7

- Stage IIA Ovarian Cancer AJCC V6 and v7

- Stage IIA1 Cervical Cancer AJCC v7

- Stage IIA2 Cervical Cancer AJCC v7

- Stage IIB Cervical Cancer AJCC v6 and v7

- Stage IIB Fallopian Tube Cancer AJCC v6 and v7

- Stage IIB Ovarian Cancer AJCC v6 and v7

- Stage IIC Fallopian Tube Cancer AJCC v6 and v7

- Stage IIC Ovarian Cancer AJCC v6 and v7

- Stage III Cervical Cancer AJCC v6 and v7

- Stage III Fallopian Tube Cancer AJCC v7

- Stage III Ovarian Cancer AJCC v6 and v7

- Stage III Primary Peritoneal Cancer AJCC v7

- Stage III Uterine Corpus Cancer AJCC v7

- Stage IIIA Cervical Cancer AJCC v6 and v7

- Stage IIIA Fallopian Tube Cancer AJCC v7

- Stage IIIA Ovarian Cancer AJCC v6 and v7

- Stage IIIA Primary Peritoneal Cancer AJCC v7

- Stage IIIA Uterine Corpus Cancer AJCC v7

- Stage IIIB Cervical Cancer AJCC v6 and v7

- Stage IIIB Fallopian Tube Cancer AJCC v7

- Stage IIIB Ovarian Cancer AJCC v6 and v7

- Stage IIIB Primary Peritoneal Cancer AJCC v7

- Stage IIIB Uterine Corpus Cancer AJCC v7

- Stage IIIC Fallopian Tube Cancer AJCC v7

- Stage IIIC Ovarian Cancer AJCC v6 and v7

- Stage IIIC Primary Peritoneal Cancer AJCC v7

- Stage IIIC Uterine Corpus Cancer AJCC v7

- Stage IIIC1 Uterine Corpus Cancer AJCC v7

- Stage IIIC2 Uterine Corpus Cancer AJCC v7

- Stage IV Cervical Cancer AJCC v6 and v7

- Stage IV Fallopian Tube Cancer AJCC v6 and v7

- Stage IV Ovarian Cancer AJCC v6 and v7

- Stage IV Primary Peritoneal Cancer AJCC v7

- Stage IV Uterine Corpus Cancer AJCC v7

- Stage IVA Cervical Cancer AJCC v6 and v7

- Stage IVA Uterine Corpus Cancer AJCC v7

- Stage IVB Cervical Cancer AJCC v6 and v7

- Stage IVB Uterine Corpus Cancer AJCC v7

- Uterine Carcinosarcoma

- Uterine Corpus Sarcoma

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients complete 3 modules of online CCI intervention.

**Intervention Names:**

- Other: Internet-Based Intervention

- Other: Quality-of-Life Assessment

- Other: Questionnaire Administration

- Other: Survey Administration

**Label:** Supportive Care (CCI intervention)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Supportive Care (CCI intervention)

**Description:** Receive CCI intervention

**Name:** Internet-Based Intervention

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Supportive Care (CCI intervention)

**Description:** Ancillary studies

**Name:** Quality-of-Life Assessment

**Other Names:**

- Quality of Life Assessment

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Supportive Care (CCI intervention)

**Description:** Ancillary studies

**Name:** Questionnaire Administration

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- Supportive Care (CCI intervention)

**Description:** Ancillary studies

**Name:** Survey Administration

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Will define feasibility/acceptability as participant's evaluation of the online intervention using both qualitative and quantitative methods. Will summarize participant?s feedback by their overall impressions, the ease of use, how much the web intervention kept their attention, how much they liked the program, feedback about how the program looked, suggestions on how to improve the look, their satisfaction with the program and why, how useful they found the program and why, how easy the information was to understand and why, to what degree they think it would make them more confident in coping with cancer, what the most and least helpful components of the program were, what aspects if any were confusing, evaluation of places where navigation were unclear, and anything they would like to add to the program.

**Measure:** Examine feasibility of an online CCI as defined by participant's evaluation of the online intervention

**Time Frame:** Up to 2 months

#### Secondary Outcomes

**Description:** Pre-post changes in the(BDI) scales will be examined. BDI has 21 items and scores range 0-63

**Measure:** Changes in psychological adaptation- Beck Depression Inventory (BDI)

**Time Frame:** Baseline up to 2 months

**Description:** Pre-post changes in the (MHI) scales will be examined t-tests. 38-item MHI measure used

**Measure:** Changes in psychological adaptation-Mental Health Inventory (MHI)

**Time Frame:** Baseline up to 2 months

**Description:** Pre-post changes in the Impact of Event Scale (IES) scales will be examined using t-tests.

**Measure:** Changes in psychological coping

**Time Frame:** Baseline up to 2 months

**Description:** Will define acceptability as participant's evaluation of the online intervention using both qualitative and quantitative methods. Will summarize participant?s feedback by their overall impressions, the ease of use, how much the web intervention kept their attention, how much they liked the program, feedback about how the program looked, suggestions on how to improve the look, their satisfaction with the program and why, how useful they found the program and why, how easy the information was to understand and why, to what degree they think it would make them more confident in coping with cancer, what the most and least helpful components of the program were, what aspects if any were confusing, evaluation of places where navigation were unclear, and anything they would like to add to the program.

**Measure:** Examine acceptability of an online CCI

**Time Frame:** Up to 2 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Newly diagnosed with any stage of primary ovarian cancer, primary peritoneal cancer, or primary fallopian tube cancer in the past 6 months
* Newly diagnosed with high grade stage 2, any grade stage 3 or higher endometrial cancer in the past 6 months
* Newly diagnosed with stage 2 or higher cervical cancer within the past 6 months
* Newly diagnosed with any stage uterine cancer (both sarcoma and carcinosarcoma) in the past 6 months
* At the time of recruitment the patient is on active treatment defined as either currently receiving chemotherapy or radiation or less than 6 months post-cancer surgery
* At the time of recruitment, a Karnofsky performance status of 80 or above or an Eastern Cooperative Oncology Group (ECOG) (80) score of 0 or 1
* English speaking
* Has internet access
* Must give informed consent within 6 months of diagnosis

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New Brunswick

**Country:** United States

**Facility:** Rutgers Cancer Institute of New Jersey

**State:** New Jersey

**Zip:** 08903

#### Overall Officials

**Official 1:**

**Affiliation:** Rutgers Cancer Institute of New Jersey

**Name:** Sharon Manne

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000010049

- Term: Ovarian Diseases

- ID: D000000291

- Term: Adnexal Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000005833

- Term: Genital Neoplasms, Female

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000091662

- Term: Genital Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000006058

- Term: Gonadal Disorders

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000012509

- Term: Sarcoma

- ID: D000018204

- Term: Neoplasms, Connective and Soft Tissue

- ID: D000014594

- Term: Uterine Neoplasms

- ID: D000002577

- Term: Uterine Cervical Diseases

- ID: D000014591

- Term: Uterine Diseases

- ID: D000005184

- Term: Fallopian Tube Diseases

- ID: D000000008

- Term: Abdominal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000010532

- Term: Peritoneal Diseases

- ID: D000018193

- Term: Neoplasms, Complex and Mixed

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M5830

- Name: Uterine Cervical Neoplasms

- Relevance: HIGH

- As Found: Cervical Cancer

- ID: M15327

- Name: Sarcoma

- Relevance: LOW

- As Found: Unknown

- ID: M12974

- Name: Ovarian Neoplasms

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: M1704

- Name: Carcinoma, Ovarian Epithelial

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: M5552

- Name: Carcinosarcoma

- Relevance: HIGH

- As Found: Carcinosarcoma

- ID: M20346

- Name: Mixed Tumor, Mullerian

- Relevance: LOW

- As Found: Unknown

- ID: M8328

- Name: Fallopian Tube Neoplasms

- Relevance: HIGH

- As Found: Fallopian Tube Cancer

- ID: M13443

- Name: Peritoneal Neoplasms

- Relevance: HIGH

- As Found: Peritoneal Cancer

- ID: M19235

- Name: Endometrial Neoplasms

- Relevance: HIGH

- As Found: Endometrial Carcinoma

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12972

- Name: Ovarian Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3643

- Name: Adnexal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8945

- Name: Genital Neoplasms, Female

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9163

- Name: Gonadal Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M20350

- Name: Neoplasms, Connective and Soft Tissue

- Relevance: LOW

- As Found: Unknown

- ID: M17342

- Name: Uterine Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5825

- Name: Uterine Cervical Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17339

- Name: Uterine Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8327

- Name: Fallopian Tube Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7

- Name: Abdominal 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: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13441

- Name: Peritoneal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T5284

- Name: Soft Tissue Sarcoma

- Relevance: LOW

- As Found: Unknown

- ID: T4352

- Name: Ovarian Cancer

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: T2189

- Name: Fallopian Tube Cancer

- Relevance: HIGH

- As Found: Fallopian Tube Cancer

- ID: T4354

- Name: Ovarian Epithelial Cancer

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: T3586

- Name: Malignant Mixed Mullerian Tumor

- Relevance: LOW

- As Found: Unknown

- ID: T5821

- Name: Uterine Sarcoma

- Relevance: HIGH

- As Found: Uterine Corpus Sarcoma

- ID: T5820

- Name: Uterine Carcinosarcoma

- Relevance: HIGH

- As Found: Uterine Carcinosarcoma

### Condition Browse Module - Meshes

- ID: D000010051

- Term: Ovarian Neoplasms

- ID: D000077216

- Term: Carcinoma, Ovarian Epithelial

- ID: D000002583

- Term: Uterine Cervical Neoplasms

- ID: D000005185

- Term: Fallopian Tube Neoplasms

- ID: D000010534

- Term: Peritoneal Neoplasms

- ID: D000016889

- Term: Endometrial Neoplasms

- ID: D000002296

- Term: Carcinosarcoma

### Misc Info Module

- Version Holder: 2024-05-24
