Journey Ahead: Enhancing Coping and Communication for Women Diagnosed With Gynecological Cancer

NCT05220033 | Active Not Recruiting DMC

• 2 other identifiers: Pro2019002089131908
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study looks at how well the Journey Ahead intervention works in improving coping and communication skills in participants with gynecologic cancers.

Conditions

Gynecologic Cancer; Ovarian Cancer; Endometrial Cancer; Cervical Cancer; Uterine Cancer; Fallopian Tube Cancer

Outcome Measures

Primary Outcomes (4)

• Depressive symptoms "change" is being assessed

  Depressive symptoms will be measures with the Beck Depression inventory which is a 21-item scale which has been widely used in studies incorporating cognitive-behavioral interventions. Calculate score bye summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63.

  Baseline, two and 6 months post-baseline

• Psychological distress and well being "change" is being assessed

  The MHI-18 has subscales for Psychological Distress (anxiety, depression and loss of behavioral and emotional control) and Well-being. can assess 4 subscales of emotional status like Anxiety, Depression, Behavioral control, and Positive affect. MHI generates one total score. The subscale and total scores range from 0 - 100, with higher scores indicate better mental health

  Baseline, two and 6 months post-baseline

• Cancer specific distress "change" is being assessed over the time points

  The Impact of Events Scale (IES) (108) is a 21-item self-report measure focusing on intrusive and avoidant ideation related to ovarian cancer and its treatment. Using a 4-point Likert scale, participants rate how true each statement has been for them during the past week (scale range = 0-75).

  Baseline, two and 6 months post-baseline

• Quality of life using the Fact-G "change" is being assessed

  The Functional Assessment of Cancer Therapy - General (FACT-G) (110) is a widely used measure of QOL. The FACT-G is comprised of 27 questions that assess well-being in four domains: physical (PWB), functional (FWB), social/family (SFWB), and emotional (EWB). PWB assesses the physical symptoms; FWB assesses the degree to which the person can participate and enjoy normal daily activities; SFWB assesses social support and communication, and EWB measures mood and emotional response to illness. The domains are summed

  Baseline, two and 6 months post-baseline

Secondary Outcomes (8)

• Physical impairment

  Baseline, two and 6 months post-baseline

• Coping "change" is being assessed

  Baseline, two and 6 months post-baseline

• Emotional Acceptance scale Change

  Baseline, two and 6 months post-baseline

• Positive emotional expression

  Baseline, two and 6 months post-baseline

• Holding back from sharing concerns

  Baseline, two and 6 months post-baseline

Other Outcomes (7)

• Demographic information

  Baseline only

• Medical information- type of cancer

  Baseline, two and 6 months post-baseline

• Working alliance inventory

  Baseline, two and 6 months post-baseline

Study Arms (1)

Journey Ahead

EXPERIMENTAL

Experimental: Journey Ahead intervention focusing on coping and communication skill development during the course of 8 sessions and 6 phone calls.

Other: Informational intervention; Other: survey administration

Interventions

Informational intervention OTHER

Receive information focusing on coping skills for patients diagnosed with gynecologic cancer

Journey Ahead

survey administration OTHER

Ancillary studies

Journey Ahead

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with any stage of primary ovarian cancer, primary peritoneal cancer, or primary fallopian tube cancer or experienced a recurrence in the past 5 years;
• Diagnosed with High Grade Stage 2, any grade Stage 3 or higher endometrial cancer or experienced a recurrence in the past 5 years;
• Diagnosed with Stage 2 or higher cervical cancer or experienced a recurrence within the past 5 years;
• Diagnosed with any stage Uterine Cancer (both Sarcoma and carcinosarcoma) or experienced a recurrence in the past 5 years;
• At the time of recruitment the patient has received chemotherapy or radiation in the past 5 years, or is less than 5 years 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;
• years of age or older;
• English speaking;
• Has internet access, able to view the online intervention sessions and attend telephone or video/telehealth chats to discuss the session content and provide feedback;
• Must give informed consent within 5 years of diagnosis.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Fallopian Tube Neoplasms; Uterine Cervical Neoplasms; Uterine Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Diseases; Fallopian Tube Diseases; Uterine Cervical Diseases

Study Officials

• Sharon L Manne, PhD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Behavioral Sciences

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: February 2, 2022
• Study Start: July 14, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)