Back to resultsJourney Ahead: Enhancing Coping and Communication for Women Diagnosed With Gynecological Cancer
Primary Purpose
Gynecologic Cancer, Ovarian Cancer, Endometrial Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Informational intervention
survey administration
Sponsored by
About this trial
This is an interventional supportive care trial for Gynecologic Cancer
Eligibility Criteria
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:
-
Sites / Locations
- Rutgers Cancer Institute of New JerseyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Journey Ahead
Arm Description
Experimental: Journey Ahead intervention focusing on coping and communication skill development during the course of 8 sessions and 6 phone calls.
Outcomes
Primary Outcome Measures
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.
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
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).
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
Secondary Outcome Measures
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.
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
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.
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.
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
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)
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
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.
Full Information
NCT ID
NCT05220033
First Posted
November 22, 2021
Last Updated
February 6, 2023
Sponsor
Rutgers, The State University of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT05220033
Brief Title
Journey Ahead: Enhancing Coping and Communication for Women Diagnosed With Gynecological Cancer
Official Title
Journey Ahead: Enhancing Coping and Communication for Women Diagnosed With Gynecological Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study looks at how well the Journey Ahead intervention works in improving coping and communication skills in participants with gynecologic cancers.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Cancer, Ovarian Cancer, Endometrial Cancer, Fallopian Tube Cancer, Cervical Cancer, Uterine Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Journey Ahead
Arm Type
Experimental
Arm Description
Experimental: Journey Ahead intervention focusing on coping and communication skill development during the course of 8 sessions and 6 phone calls.
Intervention Type
Other
Intervention Name(s)
Informational intervention
Intervention Description
Receive information focusing on coping skills for patients diagnosed with gynecologic cancer
Intervention Type
Other
Intervention Name(s)
survey administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Depressive symptoms "change" is being assessed
Description
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.
Time Frame
Baseline, two and 6 months post-baseline
Title
Psychological distress and well being "change" is being assessed
Description
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
Time Frame
Baseline, two and 6 months post-baseline
Title
Cancer specific distress "change" is being assessed over the time points
Description
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).
Time Frame
Baseline, two and 6 months post-baseline
Title
Quality of life using the Fact-G "change" is being assessed
Description
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
Time Frame
Baseline, two and 6 months post-baseline
Secondary Outcome Measure Information:
Title
Physical impairment
Description
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.
Time Frame
Baseline, two and 6 months post-baseline
Title
Coping "change" is being assessed
Description
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
Time Frame
Baseline, two and 6 months post-baseline
Title
Emotional Acceptance scale Change
Description
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.
Time Frame
Baseline, two and 6 months post-baseline
Title
Positive emotional expression
Description
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.
Time Frame
Baseline, two and 6 months post-baseline
Title
Holding back from sharing concerns
Description
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
Time Frame
Baseline, two and 6 months post-baseline
Title
Unsupportive responses from friends and family
Description
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)
Time Frame
Baseline, two and 6 months post-baseline
Title
Psychological flexibility
Description
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
Time Frame
Baseline, two and 6 months post-baseline
Title
Hope
Description
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.
Time Frame
Baseline, two and 6 months post-baseline
Other Pre-specified Outcome Measures:
Title
Demographic information
Description
items assessing age, education, ethnicity, occupation, employment status, income, religious affiliation, marital status and length of significant relationship (baseline only).
Time Frame
Baseline only
Title
Medical information- type of cancer
Description
Chart reviews at baseline will capture type of cancer
Time Frame
Baseline, two and 6 months post-baseline
Title
Working alliance inventory
Description
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.
Time Frame
Baseline, two and 6 months post-baseline
Title
Medical Outcome- time since diagnosis
Description
Chart reviews at baseline will capture time since diagnosis
Time Frame
Baseline, two and 6 months post-baseline
Title
Medical Outcome- use of medication for pain, depression, anxiety
Description
Chart reviews at baseline will capture use of medication for pain, depression, anxiety
Time Frame
Baseline, two and 6 months post-baseline
Title
Medical outcome- cancer treatment history
Description
Chart reviews at baseline will capture cancer treatment history
Time Frame
Baseline, two and 6 months post-baseline
Title
Medical outcome- sleep disturbance
Description
Chart reviews at baseline will capture sleep disturbance
Time Frame
Baseline, two and 6 months post-baseline
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon L Manne, PhD
Phone
732-3577978
Email
sharon.manne@rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon L Manne, PhD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon L Manne, PhD
Phone
732-357-7978
Email
sharon.manne@rutgers.edu
First Name & Middle Initial & Last Name & Degree
Sharon L Manne, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Journey Ahead: Enhancing Coping and Communication for Women Diagnosed With Gynecological Cancer
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