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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Cervical Cancer; Gynecologic Cancer; Ovarian Cancer; Fallopian Tube Cancer; Endometrial Cancer; Uterine Cancer
• Intervention / Treatment: Other: survey administration; Other: Informational intervention

Detailed Description

Primary goals of this project are:

Objective 1: Phase 1: To collect feedback from patients on CCI online and to assess patient's evaluation of CCI online.

Objective 2: Phase 1: To examine the feasibility and acceptability of a CCI online.

Objective 3: Phase 1/2: To collect preliminary data on changes in distress and coping associated with participation in CCI online.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Cancer Institute of New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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;
• 18 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.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Journey Ahead; Experimental: Journey Ahead intervention focusing on coping and communication skill development during the course of 8 sessions and 6 phone calls.	Other: survey administration; Ancillary studies; Other: Informational intervention; Receive information focusing on coping skills for patients diagnosed with gynecologic cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical impairment	The 26 item Physical function scale of the CARES measure asks patients to rate physical limitations on a 5-point scale. The mean of all items is calculated.	Baseline, two and 6 months post-baseline
Coping "change" is being assessed	The acceptance, positive reappraisal, and mental disengagement subscales of the COPE (Carver, Scheier, Weintraub 1989). The scale ranges from 1 = I usually don't do this at all 2 = I usually do this a little bit 3 = I usually do this a medium amount 4 = I usually do this a lot. The scale assess a broad range of coping responses	Baseline, two and 6 months post-baseline
Emotional Acceptance scale Change	The Emotional Acceptance Scale (Stanton et. al., 2000) will be administered. Thirteen items include statements such as, "I naturally and easily attend to my feelings," "I allow myself to be in touch with my feelings because it is very good for me", and "Knowing they are 'not perfect', I am comfortable with my feelings as they are." Participants indicate percentage of time they believe the statement is true for them ranging from 0 for "never" to 100 for "almost always." The total score is the average for the 13 items (range 0 - 100) and higher scores indicate more emotional acceptance.	Baseline, two and 6 months post-baseline
Positive emotional expression	Positive emotional expression is a 7 item subscale of the Emotional Expressiveness Questionnaire (King & Emmons, 1990). Items are rated on a 5-point Likert scale with 0 = Never; 1 = Rarely; 2 = Sometimes; 3 = Frequently; 4 = Always. High scores ndicate a tendency to express emotion.	Baseline, two and 6 months post-baseline
Holding back from sharing concerns	The degree to which the participant holds back from talking about cancer-related concerns with others will be measured by asking participants to rate how much each of 11 common cancer concerns is a concern and how much they hold back from talking to others about this concern. The Investigators adapted this scale from Porter and colleagues (Porter, et. al, 2005). A 13-item scale was used that measures the degree to which participants hold back from family and friends. Participants are asked to rate, on a 6-point scale, the degree to which they hold back from discussing issues of concern with friends and family. Scores are averaged to produce a total score, with higher scores indicating greater holding back	Baseline, two and 6 months post-baseline
Unsupportive responses from friends and family	The family and friend version of the perceived negative behavior scale (Manne, Pape, & Taylor, 1999) contains critical responses as well as more subtle responses of others. .Cronbach's alphas have ranged from .87 to .94 in the investigators' work with this patient population (Manne et al., 2019)	Baseline, two and 6 months post-baseline
Psychological flexibility	The 10-item Acceptance and Action Questionnaire-II will be used (AAQ-II) (Bond et. al., 2011) to assess avoidance and willingness to accept undesirable thoughts and feelings while acting in congruence with personal values and goals. a 1 = never true up to 7 = always true. Higher total scores mean less flexibility, while lower total scores mean more flexibility	Baseline, two and 6 months post-baseline
Hope	The 6-item State Hope Scale (SHS; Snyder, Sympson, Ybasco, Borders, Babyak, & Higgins, 1996) measures agency (belief in one's ability to reach goals) and pathways (belief in one's ability to find routes to reach goals). Individuals rate how true or false each statement (e.g., "I can think of many ways to reach my current goals.") is for them right now on a scale of 1 (Definitely false) to 8 (Definitely true). Total scores range from 6-48 and subscale scores range from 3-24.	Baseline, two and 6 months post-baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic information	items assessing age, education, ethnicity, occupation, employment status, income, religious affiliation, marital status and length of significant relationship (baseline only).	Baseline only
Medical information- type of cancer	Chart reviews at baseline will capture type of cancer	Baseline, two and 6 months post-baseline
Working alliance inventory	The WAI Short Form (WAI-S) is a 12 item inventory rated on a 7-point Likert scale (A. O. Horvath, 1981, 2010). The measure has three alliance subscales: Bond, Task, and Goal.	Baseline, two and 6 months post-baseline
Medical Outcome- time since diagnosis	Chart reviews at baseline will capture time since diagnosis	Baseline, two and 6 months post-baseline
Medical Outcome- use of medication for pain, depression, anxiety	Chart reviews at baseline will capture use of medication for pain, depression, anxiety	Baseline, two and 6 months post-baseline
Medical outcome- cancer treatment history	Chart reviews at baseline will capture cancer treatment history	Baseline, two and 6 months post-baseline
Medical outcome- sleep disturbance	Chart reviews at baseline will capture sleep disturbance	Baseline, two and 6 months post-baseline

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Sharon L Manne, PhD, Rutgers Cancer Institute of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Uterine Cervical Diseases; Fallopian Tube Diseases; Ovarian Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms; Fallopian Tube Neoplasms; Uterine Neoplasms
• Other Study ID Numbers: Pro2019002089; 131908 (Other Identifier: Rutgers, The State University of New Jersey)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No