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Coping and Communication Skills Training for Gynecologic Cancers
N/A
Recruiting
Led By Sharon L Manne, PhD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with Stage 2 or higher cervical cancer or experienced a recurrence within the past 5 years;
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;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, two and 6 months post-baseline
Awards & highlights
Study Summary
This trial found that Journey Ahead was helpful in teaching communication and coping skills to women with gynecologic cancers.
Who is the study for?
This trial is for women over 18 who've been diagnosed with various gynecological cancers, including uterine, ovarian, and cervical cancer. Participants should be within 5 years post-cancer surgery or treatment like chemo or radiation and must have internet access to view online sessions.Check my eligibility
What is being tested?
The 'Journey Ahead' intervention is being tested to see if it helps improve coping and communication skills in women with gynecologic cancers. It involves informational sessions viewed online followed by discussions via phone or video chat.See study design
What are the potential side effects?
Since this study focuses on an informational intervention rather than a medical treatment, traditional physical side effects are not expected. However, discussing sensitive topics may cause emotional discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with Stage 2 or higher cervical cancer or had a recurrence in the last 5 years.
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I am mostly active and can carry out my daily activities.
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I've had cancer treatment or surgery within the last 5 years.
Select...
I was diagnosed with ovarian, peritoneal, or fallopian tube cancer or had a recurrence in the last 5 years.
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I was diagnosed with advanced or recurrent endometrial cancer in the last 5 years.
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I have been diagnosed with uterine cancer or it has come back in the last 5 years.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, two and 6 months post-baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, two and 6 months post-baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cancer specific distress "change" is being assessed over the time points
Depressive symptoms "change" is being assessed
Psychological distress and well being "change" is being assessed
+1 moreSecondary outcome measures
Coping "change" is being assessed
Emotional Acceptance scale Change
Holding back from sharing concerns
+5 moreOther outcome measures
Demographic information
Medical Outcome- time since diagnosis
Medical Outcome- use of medication for pain, depression, anxiety
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Journey AheadExperimental Treatment2 Interventions
Experimental: Journey Ahead intervention focusing on coping and communication skill development during the course of 8 sessions and 6 phone calls.
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Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
430 Previous Clinical Trials
64,628 Total Patients Enrolled
5 Trials studying Ovarian Cancer
393 Patients Enrolled for Ovarian Cancer
Sharon L Manne, PhDPrincipal InvestigatorRutgers Cancer Institute of New Jersey
2 Previous Clinical Trials
1,164 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with Stage 2 or higher cervical cancer or had a recurrence in the last 5 years.I can access the internet and participate in online sessions and telehealth chats.I am mostly active and can carry out my daily activities.I was diagnosed with ovarian, peritoneal, or fallopian tube cancer or had a recurrence in the last 5 years.I was diagnosed within the last 5 years and agree to participate.I've had cancer treatment or surgery within the last 5 years.I was diagnosed with advanced or recurrent endometrial cancer in the last 5 years.I have been diagnosed with uterine cancer or it has come back in the last 5 years.I am 18 years old or older.You can speak English.
Research Study Groups:
This trial has the following groups:- Group 1: Journey Ahead
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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