Clinical trial NCT05220033: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gynecologic Cancer
Ovarian Cancer
Endometrial Cancer
Fallopian Tube Cancer
Cervical Cancer
Uterine Cancer
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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:

-

Primary outcomes:
measure: Depressive symptoms "change" is being assessed
timeFrame: Baseline, two and 6 months post-baseline
measure: Psychological distress and well being "change" is being assessed
timeFrame: Baseline, two and 6 months post-baseline
measure: Cancer specific distress "change" is being assessed over the time points
timeFrame: Baseline, two and 6 months post-baseline
measure: Quality of life using the Fact-G "change" is being assessed
timeFrame: Baseline, two and 6 months post-baseline
Secondary outcomes:
measure: Physical impairment
timeFrame: Baseline, two and 6 months post-baseline
measure: Coping "change" is being assessed
timeFrame: Baseline, two and 6 months post-baseline
measure: Emotional Acceptance scale Change
timeFrame: Baseline, two and 6 months post-baseline
measure: Positive emotional expression
timeFrame: Baseline, two and 6 months post-baseline
measure: Holding back from sharing concerns
timeFrame: Baseline, two and 6 months post-baseline
measure: Unsupportive responses from friends and family
timeFrame: Baseline, two and 6 months post-baseline
measure: Psychological flexibility
timeFrame: Baseline, two and 6 months post-baseline
measure: Hope
timeFrame: Baseline, two and 6 months post-baseline
Other outcomes:
measure: Demographic information
timeFrame: Baseline only
measure: Medical information- type of cancer
timeFrame: Baseline, two and 6 months post-baseline
measure: Working alliance inventory
timeFrame: Baseline, two and 6 months post-baseline
measure: Medical Outcome- time since diagnosis
timeFrame: Baseline, two and 6 months post-baseline
measure: Medical Outcome- use of medication for pain, depression, anxiety
timeFrame: Baseline, two and 6 months post-baseline
measure: Medical outcome- cancer treatment history
timeFrame: Baseline, two and 6 months post-baseline
measure: Medical outcome- sleep disturbance
timeFrame: Baseline, two and 6 months post-baseline
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Sharon L Manne, PhD
role: PRINCIPAL_INVESTIGATOR
References: