What side effects are associated with this type of intervention?

Common treatments for ovarian cancer include chemotherapy, radiation therapy, and surgery. Chemotherapy can cause side effects such as nausea, vomiting, hair loss, fatigue, and increased risk of infection. Radiation therapy may lead to skin irritation, fatigue, and localized pain. Surgery can result in pain, risk of infection, and longer recovery times. Psychosocial and behavioral interventions, like those studied in the Journey Ahead trial, aim to improve coping and communication skills and generally have minimal physical side effects, though they may involve emotional challenges as patients work through their experiences.

What prior FDA approvals exist?

FDA-approved treatments for ovarian cancer include chemotherapeutic agents such as paclitaxel, topotecan, and pegylated liposomal doxorubicin. Additionally, targeted therapies like bevacizumab and PARP inhibitors (e.g., olaparib, niraparib) have been approved. While these treatments focus on the medical management of ovarian cancer, the Journey Ahead trial explores psychosocial and behavioral interventions to improve coping and communication skills, which are not typically covered by FDA drug approvals but are crucial for comprehensive patient care.

What other types of research exist?

Promising alternatives to Journey Ahead for ovarian cancer patients include: 1) Mindfulness-Based Stress Reduction (MBSR), which has shown efficacy in reducing psychological distress and improving quality of life in cancer patients. 2) Cognitive Behavioral Therapy (CBT), particularly online-based CBT, which has been effective in managing chronic pain and psychological symptoms. 3) Acceptance and Commitment Therapy (ACT), especially online-based ACT, which has demonstrated benefits in chronic pain management and psychological well-being. 4) Guided Web-Based Self-Help Interventions, which have been effective in preventing depression in patients with chronic conditions. These interventions offer accessible and effective options for improving coping and communication skills in ovarian cancer patients.

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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

No Placebo-Only Group

Summary

This trial tests the Journey Ahead online program, which helps people with gynecologic cancers improve their coping and communication skills. The program includes educational content and activities to reduce stress and enhance emotional management. Researchers will gather feedback from participants and assess the program's effectiveness.

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.

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.

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 below

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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.

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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.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, two and 6 months post-baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

Coping "change" is being assessed

Emotional Acceptance scale Change

Holding back from sharing concerns

+5 more

Other study objectives

Demographic information

Medical Outcome- time since diagnosis

Medical Outcome- use of medication for pain, depression, anxiety

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ovarian cancer include surgery, chemotherapy, and targeted therapy. However, psychosocial and behavioral interventions, such as those studied in the Journey Ahead trial, focus on improving coping and communication skills. These interventions work by providing patients with strategies to manage stress, enhance emotional well-being, and improve interpersonal relationships. This is crucial for ovarian cancer patients as it can lead to better mental health, improved quality of life, and potentially better adherence to medical treatments.

Predicting sexual and psychologic morbidity and improving the quality of life for women with gynecologic cancer.Improvement in sexual function after ovarian cancer: Effects of sexual therapy and rehabilitation after treatment for ovarian cancer.