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Web-Based Programs for Ovarian Cancer Survivors

N/A

Recruiting

Led By Susan K Lutgendorf, PhD

Research Sponsored by Susan Lutgendorf

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Survivors 18 years or older with a cytological or histological diagnosis of any stage of epithelial ovarian cancer, peritoneal cancer, fallopian tube cancer, or cancer of Mullerian origin consistent with ovarian/fallopian tube/peritoneal origin (not consistent with endometrial cancer)

Women who were not recommended to receive adjuvant chemotherapy are eligible after surgery alone

Must not have

Currently receiving primary chemotherapy

Non-epithelial ovarian cancer, ovarian tumors of low malignant potential ("borderline"), cancers originating from other organs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up mean change from pre-intervention baseline to completion of the 10 week intervention (t2), 6 months post-baseline,12 months post-baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of two different interventions on quality of life and stress levels in ovarian cancer survivors.

Who is the study for?

This trial is for English-speaking ovarian cancer survivors, aged 18 or older, who have completed primary treatment within the last 5 years. Participants can be undergoing maintenance therapy but must not have had more than one recurrence of cancer. They should be willing to participate in a web-based program and follow-up for a year.

What is being tested?

The study tests two web-delivered programs: Mindful Living (ML) aims to improve quality of life and reduce stress, while Healthy Lifestyles (HL) promotes health education. The effectiveness will be measured over a year by looking at participants' quality of life, stress levels, mood changes, anxiety, and fatigue.

What are the potential side effects?

Since this trial involves psychosocial interventions rather than medications or invasive procedures, traditional physical side effects are not expected. However, participants may experience emotional discomfort when discussing personal experiences related to their cancer journey.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an adult survivor of ovarian, peritoneal, fallopian tube, or similar cancer.

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I had surgery for my condition without being advised to undergo additional chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently undergoing my first round of chemotherapy.

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My ovarian cancer is not the common type and did not start in my ovaries.

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I am between 18 and 90 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ mean change from pre-intervention baseline to completion of the 10 week intervention (t2), 6 months post-baseline,12 months post-baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~mean change from pre-intervention baseline to completion of the 10 week intervention (t2), 6 months post-baseline,12 months post-baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and mean change from pre-intervention baseline to completion of the 10 week intervention (t2), 6 months post-baseline,12 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

Change in HRQOL from baseline (T1) across a 12-month interval post randomization :((T4) Long-term change)

Change in HRQOL from baseline (T1) to T2 (immediate change: post-intervention).

Change in Perceived Stress from baseline (T1) across a 12-month interval post randomization: ((T4) Long-term change)

+1 more

Secondary study objectives

Change in CESD (depressive mood) from baseline (T1) to T2 (immediate change: post-intervention).

Change in CESD from baseline (T1) across a 12-month interval post randomization :((T4) Long-term change)

Change in anxiety from baseline (T1) across a 12-month interval post randomization :((T4) Long-term change)

+3 more

Other study objectives

Statistical correlations between change in stress management skills, mindfulness, cognitive coping, acceptance, and relaxation frequency and changes in HRQOL, Depressive Mood, Perceived Stress, anxiety and fatigue.

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mindful Living (ML)Experimental Treatment1 Intervention

Mindful Living Intervention A 10-week group-based and web-delivered psychosocial intervention targeting key concerns of ovarian cancer survivors.

Group II: Healthy Lifestyles (HL)Active Control1 Intervention

Healthy Lifestyle Intervention A 10-week group-based and web-delivered intervention providing information on health promotion for ovarian cancer survivors.

0 / 5Eligibility criteria met