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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05220033
• Other study ID #: Pro2019002089
• Secondary ID: 131908
• Status: Recruiting
• Phase: N/A
• Start date: July 14, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: Rutgers, The State University of New Jersey
• Contact: Sharon L Manne, PhD
• Phone: 732-3577978
• Email: sharon.manne[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Cervical Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Gynecologic Cancer
• Ovarian Cancer
• Uterine Cancer
• Uterine Neoplasms

Intervention

Other:
• Informational intervention
Receive information focusing on coping skills for patients diagnosed with gynecologic cancer
• survey administration
Ancillary studies

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic information	items assessing age, education, ethnicity, occupation, employment status, income, religious affiliation, marital status and length of significant relationship (baseline only).	Baseline only
Other	Medical information- type of cancer	Chart reviews at baseline will capture type of cancer	Baseline, two and 6 months post-baseline
Other	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
Other	Medical Outcome- time since diagnosis	Chart reviews at baseline will capture time since diagnosis	Baseline, two and 6 months post-baseline
Other	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
Other	Medical outcome- cancer treatment history	Chart reviews at baseline will capture cancer treatment history	Baseline, two and 6 months post-baseline
Other	Medical outcome- sleep disturbance	Chart reviews at baseline will capture sleep disturbance	Baseline, two and 6 months post-baseline
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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