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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

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

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 outcome measures

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.

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Susan LutgendorfLead Sponsor

1 Previous Clinical Trials

613 Total Patients Enrolled

University of WashingtonOTHER

1,740 Previous Clinical Trials

1,847,378 Total Patients Enrolled

6 Trials studying Ovarian Cancer

213 Patients Enrolled for Ovarian Cancer

University of MiamiOTHER

901 Previous Clinical Trials

409,694 Total Patients Enrolled

2 Trials studying Ovarian Cancer

200 Patients Enrolled for Ovarian Cancer

Media Library

Technology-based Mindful Living program Clinical Trial Eligibility Overview. Trial Name: NCT04533763 — N/A

Ovarian Cancer Research Study Groups: Mindful Living (ML), Healthy Lifestyles (HL)

Ovarian Cancer Clinical Trial 2023: Technology-based Mindful Living program Highlights & Side Effects. Trial Name: NCT04533763 — N/A

Technology-based Mindful Living program 2023 Treatment Timeline for Medical Study. Trial Name: NCT04533763 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the intended outcome of this research?

"The primary goal of this clinical trial, assessed through changes in perceived stress from pre-intervention baseline to 6 months post-baseline (T3), is to observe long term effects. Secondary objectives include immediate and long term change in fatigue as measured by the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F). Higher scores represent lower levels of fatigue."

Answered by AI

What is the uppermost limit of participants for this study?

"To commence this clinical trial, 256 individuals who meet the predetermined eligibility requirements are needed. Patients have the option of participating at either Fred Hutch/University of Washington Cancer Consortium in Seattle or University of Miami in Florida."

Answered by AI

Is this clinical trial open to elderly individuals?

"This medical trial is looking for participants over 18 years old and under 90 years of age."

Answered by AI

Does this experiment require any additional participants?

"Affirmative. Records on clinicaltrials.gov demonstrate that this medical research, which was first unveiled on September 30th 2020, is currently recruiting patients. 256 people need to be enrolled from 3 distinct healthcare facilities."

Answered by AI

Are there any prerequisites for enrolling in this research study?

"This clinical trial seeks out 256 individuals who have been diagnosed with ovarian cancer, aged between 18 and 90. The eligibility criteria for potential participants is as follows: those that were recently diagnosed (within the last 5 years) of any stage epithelial ovarian cancer, peritoneal cancer, fallopian tube cancer or Mullerian origin consistent with said cancers; being over the age of 18; having finished primary treatment consisting of chemotherapy and surgery or solely chemotherapy if neccessary; not receiving active therapy for another condition at time of participation in this study ; fluency in spoken English to understand intervention methods; comprehension and willingness to sign a written informed consent document"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Living WELL: A Web-Based Program for Ovarian Cancer Survivors

Susan Lutgendorf 2020. "Living WELL: A Web-Based Program for Ovarian Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04533763.

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