Ovarian CancerNCT04533763
Living WELL: A Web-Based Program for Ovarian Cancer Survivors
A study testing Technology-based Mindful Living program and Technology-based Healthy Lifestyles program in people with Ovarian Cancer, run by Susan Lutgendorf at 4 sites in United States.
Trial summary
The purpose of this study is to determine the efficacy of a group-based and web-delivered psychosocial intervention for ovarian cancer survivors (Mindful Living [ML]) compared to a health promotion condition (Healthy Lifestyles [HL]) in increasing health related quality of life (HRQOL) and decreasing perceived stress… Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Technology-based Mindful Living program and Technology-based Healthy Lifestyles program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 341 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Sep 2020to 7 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Survivors 18 (19 at UNMC since age of Majority is 19 in Nebraska) 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). Individuals diagnosed with synchronous ovarian and endometrial cancer primaries may be included if the initial endometrial cancer was stage I.
- Survivors who have completed primary treatment (surgery and chemotherapy or chemotherapy alone for a new diagnosis ovarian/peritoneal/fallopian tube cancer within the last 5 years). Date of completion of primary treatment is defined as within approximately 60 days after the last chemotherapy infusion. Maintenance therapy infusions do not count in determining date of completion of primary therapy. Women who were not recommended to receive adjuvant chemotherapy (for example, in the case of certain stage IA/IB cancers) are eligible after surgery alone. Women receiving consolidation or maintenance therapy following primary chemotherapy or following treatment for first recurrence are eligible.
- Survivors must not have had more than one recurrence. Those who have had one recurrence will be eligible if they have completed active therapy for their recurrence.
- Although most women meeting the above criteria will be in remission, complete clinical remission (normal tumor markers and normal CT scan) is not a requirement for eligibility. Even women with low-level disease after completion of cytotoxic chemotherapy who do not meet the strict definition of remission may have stable disease and may not require additional cytotoxic chemotherapy for a prolonged period of time, particularly if they are on maintenance therapy. If subjects recur during the group they will be allowed to continue to participate, as able, even while taking chemotherapy.
- Survivors must be fluent in spoken English (6th grade level), which is necessary to participate in the intervention.
- Survivors must be willing to be randomized and followed for 12 months.
Show all 13Show fewer
- Survivors must be able to understand and willing to sign a written informed consent document.
- Survivors currently involved in the STEPS through Ovarian Cancer program will need to wait until their involvement is completed to participate.
- Survivors receiving active treatment for another cancer may be eligible when their treatment is completed.
- Temporary Exclusion:
- Survivors involved in Steps through OC must wait until they have completed that program to participate.
- Survivors currently involved in a study involving another behavioral intervention or an exercise intervention must wait until the prior study is over to participate.
- Survivors who score greater than or equal to 24 on the CESD can be rescreened when their depressive symptoms resolve.
Who cannot join
- Non-epithelial ovarian cancer, ovarian tumors of low malignant potential ("borderline"), cancers originating from other organs. Survivor who have a history of a prior cancer besides their ovarian cancer will be considered eligible as long as they are not in active therapy for said other prior cancer.
- History of prior inpatient psychiatric treatment for severe mental illness (e.g. psychosis) or current psychosis, history of bipolar disorder or schizophrenia in the last 2 years or current bipolar disorder or schizophrenia, current major depression, history of substance use disorder in the last 2 years or current substance dependence, organic mental disorder (e.g., dementia), or substance use disorder in the last 2 years.
- Survivors who are younger than 18 or older than 90 years of age
- Unable to meet study requirements
- Currently receiving primary chemotherapy.
- History of depression is not excluded as long as the patient is not currently depressed
- Survivors who are currently depressed as indicated by a CES-D Score ≥ 24 (can be rescreened once the depressive symptoms resolve).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
University of Miami
Miami, Florida, 33146
University of Nebraska Medical Center
Omaha, Nebraska, 68198
University of Washington Cancer Consortium
Seattle, Washington, 98195
About this study
Official title: Living WELL: A Web-Based Program to Improve Quality of Life in Rural and Urban Ovarian Cancer Survivors
The purpose of this study is to determine the efficacy of a group-based and web-delivered psychosocial intervention for ovarian cancer survivors (Mindful Living [ML]) compared to a health promotion condition (Healthy Lifestyles [HL]) in increasing health related quality of life (HRQOL) and decreasing perceived stress (primary aim), and decreasing anxiety, depressive mood, and fatigue (secondary aims) across a 12-month period.
Read the detailed description
Living WELL is a randomized clinical trial examining two different programs for helping ovarian cancer survivors cope and improve the quality of their lives following treatment. The programs include techniques and information to enhance both mental and physical well-being. The study is conducted through an internet video conferencing platform and is open to survivors in all parts of the US. The purpose of this study is to examine the effects of various factors such as emotions, stress management and coping techniques, and health information on quality of life, stress levels, depression, fatigue, and distress in ovarian cancer survivors. Participants are randomized into either a Mindful Living group (targeting stress management skills - e.g., relaxation, coping) or a Healthy Lifestyles group (targeting health promotion strategies - e.g, nutrition, sleep, exercise). Participation in this study includes taking part in an introductory online meeting, 10 consecutive weekly online sessions, and follow-up meetings at approximately 4.5 and 9 months following randomization. Each session will be 1.5-2 hours. Participants will complete surveys online prior to beginning the program, within a week after the 10-week program is completed, and at 6 months and 12 months later.
- Conditions
- Ovarian Cancer
- Being tested
- Technology-based Mindful Living program, Technology-based Healthy Lifestyles program
- Keywords
- ovarian cancer, behavioral, mindfulness, lifestyle, CBT, health promotion, telemedicine
- Medical subject headings
- Ovarian Neoplasms, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-based Mindful Living programBehavioural
The program is delivered using web-based group conferencing. During each session, participants are taught new stress management and coping techniques. Each week there is opportunity to apply techniques to real world situations for practice. Participants have a group orientation session, and then meet for 10 weeks. Group sessions last 1.5 - 2 hours. Booster sessions occur approximately 4.5 and 9 months post- randomization. Program includes training in mindfulness, cognitive behavioral stress management, relaxation, imagery, prioritizing meaningful activities, communication, and coping strategies. Content is geared toward concerns of cancer survivors.
Technology-based Healthy Lifestyles programBehavioural
The program is delivered using web-based group conferencing. Sessions include content from the National Cancer Institute, American Cancer Society, and health care providers with expertise in oncology. All content is geared to promoting healthy living among ovarian cancer survivors. Participants have a group orientation session, and then meet for 10 weeks, with group sessions lasting 1.5 - 2 hours. Booster sessions occur approximately 4.5 and 9 months post-randomization. Healthy Lifestyle sessions include topics such as nutrition, exercise, sleep, quality of life, survivorship, and cognitive function with content geared toward concerns of cancer survivors.
| Study group | Role | What they receive |
|---|---|---|
| Mindful Living (ML) | Experimental | Mindful Living Intervention A 10-week group-based and web-delivered psychosocial intervention targeting key concerns of ovarian cancer survivors. Receives: Behavioral: Technology-based Mindful Living program |
| Healthy Lifestyles (HL) | Active comparator | Healthy Lifestyle Intervention A 10-week group-based and web-delivered intervention providing information on health promotion for ovarian cancer survivors. Receives: Behavioral: Technology-based Healthy Lifestyles program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HRQOL from baseline (T1) to T2 (immediate change: post-intervention).
HRQOL will be measured by the Functional Assessment of Cancer Therapy (FACT-O) survey, a health survey designed to assess multiple dimensions of HRQOL. Higher scores indicate better HRQOL.
Measured: Mean change from pre-intervention baseline to T2 (after completion of the 10 week intervention)
Change in HRQOL from baseline (T1) across a 12-month interval post randomization :((T4) Long-term change)
HRQOL will be measured by the Functional Assessment of Cancer Therapy (FACT-O) survey, a health survey designed to assess multiple dimensions of HRQOL. Higher scores indicate better HRQOL Linear mixed models for repeated measures will be used to test for efficacy with p values adjusted using Bonferroni methods to account for the two timepoints.
Measured: 6 months to 12 months post-baseline (T4)
Change in Perceived Stress from baseline (T1) to T2 (immediate change: post-intervention).
Perceived Stress will be measured by the Perceived Stress Scale (PSS) a scale commonly used to assess subjective levels of stress. Higher scores indicate more stress.
Measured: Mean change from pre-intervention baseline to T2 (after completion of the 10 week intervention)
Change in Perceived Stress from baseline (T1) across a 12-month interval post randomization: ((T4) Long-term change)
Perceived Stress will be measured by the Perceived Stress Scale (PSS) a scale commonly used to assess subjective levels of stress. Higher scores indicate more stress. Linear mixed models for repeated measures will be used to test for efficacy with p values adjusted using Bonferroni methods to account for the two timepoints.
Measured: 6 months to 12 months post-baseline (T4)
Secondary outcomes (6)
Change in anxiety from baseline (T1) to T2 (immediate change: post-intervention)
Anxiety will be measured by the Profile of Mood States short form Anxiety subscale. Higher scores indicate greater anxiety.
Measured: Mean change from pre-intervention baseline to T2 (after completion of the 10 week intervention)
Change in anxiety from baseline (T1) across a 12-month interval post randomization :((T4) Long-term change)
Anxiety will be measured by the Profile of Mood States short form Anxiety subscale. Higher scores indicate higher levels of anxiety Linear mixed models for repeated measures will be used to test for efficacy with p values adjusted using Bonferroni methods to account for the two timepoints.
Measured: 6 months to 12 months post-baseline (T4)
Change in fatigue from baseline (T1) to T2 (immediate change: post-intervention).
Fatigue will be measured by the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F). Higher scores represent lower levels of fatigue.
Measured: Mean change from pre-intervention baseline to T2 (after completion of the 10 week intervention)
Change in fatigue from baseline (T1) across a 12-month interval post randomization :((T4) Long-term change)
Fatigue will be measured by the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F). Higher scores represent lower levels of fatigue. Linear mixed models for repeated measures will be used to test for efficacy with p values adjusted using Bonferroni methods to account for the two timepoints.
Measured: 6 months to 12 months post-baseline (T4)
Change in CESD (depressive mood) from baseline (T1) to T2 (immediate change: post-intervention).
Depressive Mood will be measured by the Center for Epidemiological Studies Depression (CES-D) scale. Higher scores indicate higher levels of depressive mood.
Measured: Mean change from pre-intervention baseline to T2 (after completion of the 10 week intervention)
Change in CESD from baseline (T1) across a 12-month interval post randomization :((T4) Long-term change)
Depressive Mood will be measured by the Center for Epidemiological Studies Depression (CES-D) scale. Higher scores indicate higher levels of depressive mood. Linear mixed models for repeated measures will be used to test for efficacy with p values adjusted using Bonferroni methods to account for the two timepoints.
Measured: 6 months to 12 months post-baseline (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start30 Sep 2020
- Primary completion7 Jan 2026
- Study completion7 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susan Lutgendorf
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, University of Miami, University of Iowa, National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Susan Lutgendorf, University of Iowa
- Investigators
- Susan K Lutgendorf, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533763
- Sponsor's protocol ID
- 201911073
- Other IDs
- 5R01CA246540-02
- Status last verified
- May 2026
- First submitted
- 18 Jun 2020
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pennington KP, Schlumbrecht M, McGregor BA, Goodheart MJ, Heron L, Zimmerman B, Telles R, Zia S, Penedo FJ, Lutgendorf SK. Living Well: Protocol for a web-based program to improve quality of life in rural and urban ovarian cancer survivors. Contemp Clin Trials. 2024 Sep;144:107612. doi: 10.1016/j.cct.2024.107612. Epub 2024 Jun 22.
PubMed 38914309
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living WELL: A Web-Based Program to Improve Quality of Life in Rural and Urban Ovarian Cancer Survivors
- ClinicalTrials.gov ID
- NCT04533763
- Acronym / sponsor ID
- 201911073
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, behavioral, mindfulness, lifestyle, CBT, health promotion, telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Susan LutgendorfUniversity, hospital or other
- Collaborators
- University of Washington, University of Miami, University of Iowa, National Cancer Institute (NCI)
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 7 Jan 2026 (actual)
- Study completion
- 7 Jan 2026 (actual)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy of a group-based and web-delivered psychosocial intervention for ovarian cancer survivors (Mindful Living [ML]) compared to a health promotion condition (Healthy Lifestyles [HL]) in increasing health related quality of life (HRQOL) and decreasing perceived stress (primary aim), and decreasing anxiety, depressive mood, and fatigue (secondary aims) across a 12-month period.
Detailed description
Living WELL is a randomized clinical trial examining two different programs for helping ovarian cancer survivors cope and improve the quality of their lives following treatment. The programs include techniques and information to enhance both mental and physical well-being. The study is conducted through an internet video conferencing platform and is open to survivors in all parts of the US. The purpose of this study is to examine the effects of various factors such as emotions, stress management and coping techniques, and health information on quality of life, stress levels, depression, fatigue, and distress in ovarian cancer survivors. Participants are randomized into either a Mindful Living group (targeting stress management skills - e.g., relaxation, coping) or a Healthy Lifestyles group (targeting health promotion strategies - e.g, nutrition, sleep, exercise). Participation in this study includes taking part in an introductory online meeting, 10 consecutive weekly online sessions, and follow-up meetings at approximately 4.5 and 9 months following randomization. Each session will be 1.5-2 hours. Participants will complete surveys online prior to beginning the program, within a week after the 10-week program is completed, and at 6 months and 12 months later.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Living (ML) | Experimental | Behavioral: Technology-based Mindful Living programMindful Living Intervention A 10-week group-based and web-delivered psychosocial intervention targeting key concerns of ovarian cancer survivors. |
| Healthy Lifestyles (HL) | Active comparator | Behavioral: Technology-based Healthy Lifestyles programHealthy Lifestyle Intervention A 10-week group-based and web-delivered intervention providing information on health promotion for ovarian cancer survivors. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Survivors 18 (19 at UNMC since age of Majority is 19 in Nebraska) 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). Individuals diagnosed with synchronous ovarian and endometrial cancer primaries may be included if the initial endometrial cancer was stage I.
- Survivors who have completed primary treatment (surgery and chemotherapy or chemotherapy alone for a new diagnosis ovarian/peritoneal/fallopian tube cancer within the last 5 years). Date of completion of primary treatment is defined as within approximately 60 days after the last chemotherapy infusion. Maintenance therapy infusions do not count in determining date of completion of primary therapy. Women who were not recommended to receive adjuvant chemotherapy (for example, in the case of certain stage IA/IB cancers) are eligible after surgery alone. Women receiving consolidation or maintenance therapy following primary chemotherapy or following treatment for first recurrence are eligible.
- Survivors must not have had more than one recurrence. Those who have had one recurrence will be eligible if they have completed active therapy for their recurrence.
- Although most women meeting the above criteria will be in remission, complete clinical remission (normal tumor markers and normal CT scan) is not a requirement for eligibility. Even women with low-level disease after completion of cytotoxic chemotherapy who do not meet the strict definition of remission may have stable disease and may not require additional cytotoxic chemotherapy for a prolonged period of time, particularly if they are on maintenance therapy. If subjects recur during the group they will be allowed to continue to participate, as able, even while taking chemotherapy.
- Survivors must be fluent in spoken English (6th grade level), which is necessary to participate in the intervention.
Key exclusion criteria (7 listed)
- Non-epithelial ovarian cancer, ovarian tumors of low malignant potential ("borderline"), cancers originating from other organs. Survivor who have a history of a prior cancer besides their ovarian cancer will be considered eligible as long as they are not in active therapy for said other prior cancer.
- History of prior inpatient psychiatric treatment for severe mental illness (e.g. psychosis) or current psychosis, history of bipolar disorder or schizophrenia in the last 2 years or current bipolar disorder or schizophrenia, current major depression, history of substance use disorder in the last 2 years or current substance dependence, organic mental disorder (e.g., dementia), or substance use disorder in the last 2 years.
- Survivors who are younger than 18 or older than 90 years of age
- Unable to meet study requirements
- Currently receiving primary chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology-based Mindful Living programThe program is delivered using web-based group conferencing. During each session, participants are taught new stress management and coping techniques. Each week there is opportunity to apply techniques to real world situations for practice. Participants have a group orientation session, and then meet for 10 weeks. Group sessions last 1.5 - 2 hours. Booster sessions occur approximately 4.5 and 9 months post- randomization. Program includes training in mindfulness, cognitive behavioral stress management, relaxation, imagery, prioritizing meaningful activities, communication, and coping strategies. Content is geared toward concerns of cancer survivors. | Behavioural | Mindful Living (ML) |
| Technology-based Healthy Lifestyles programThe program is delivered using web-based group conferencing. Sessions include content from the National Cancer Institute, American Cancer Society, and health care providers with expertise in oncology. All content is geared to promoting healthy living among ovarian cancer survivors. Participants have a group orientation session, and then meet for 10 weeks, with group sessions lasting 1.5 - 2 hours. Booster sessions occur approximately 4.5 and 9 months post-randomization. Healthy Lifestyle sessions include topics such as nutrition, exercise, sleep, quality of life, survivorship, and cognitive function with content geared toward concerns of cancer survivors. | Behavioural | Healthy Lifestyles (HL) |
Primary outcome
Change in HRQOL from baseline (T1) to T2 (immediate change: post-intervention).
Time frame: Mean change from pre-intervention baseline to T2 (after completion of the 10 week intervention)
HRQOL will be measured by the Functional Assessment of Cancer Therapy (FACT-O) survey, a health survey designed to assess multiple dimensions of HRQOL. Higher scores indicate better HRQOL.
Change in HRQOL from baseline (T1) across a 12-month interval post randomization :((T4) Long-term change)
Time frame: 6 months to 12 months post-baseline (T4)
HRQOL will be measured by the Functional Assessment of Cancer Therapy (FACT-O) survey, a health survey designed to assess multiple dimensions of HRQOL. Higher scores indicate better HRQOL Linear mixed models for repeated measures will be used to test for efficacy with p values adjusted using Bonferroni methods to account for the two timepoints.
Change in Perceived Stress from baseline (T1) to T2 (immediate change: post-intervention).
Time frame: Mean change from pre-intervention baseline to T2 (after completion of the 10 week intervention)
Perceived Stress will be measured by the Perceived Stress Scale (PSS) a scale commonly used to assess subjective levels of stress. Higher scores indicate more stress.
Change in Perceived Stress from baseline (T1) across a 12-month interval post randomization: ((T4) Long-term change)
Time frame: 6 months to 12 months post-baseline (T4)
Perceived Stress will be measured by the Perceived Stress Scale (PSS) a scale commonly used to assess subjective levels of stress. Higher scores indicate more stress. Linear mixed models for repeated measures will be used to test for efficacy with p values adjusted using Bonferroni methods to account for the two timepoints.
6 secondary outcomes
Change in anxiety from baseline (T1) to T2 (immediate change: post-intervention)
Time frame: Mean change from pre-intervention baseline to T2 (after completion of the 10 week intervention)
Change in anxiety from baseline (T1) across a 12-month interval post randomization :((T4) Long-term change)
Time frame: 6 months to 12 months post-baseline (T4)
Change in fatigue from baseline (T1) to T2 (immediate change: post-intervention).
Time frame: Mean change from pre-intervention baseline to T2 (after completion of the 10 week intervention)
Change in fatigue from baseline (T1) across a 12-month interval post randomization :((T4) Long-term change)
Time frame: 6 months to 12 months post-baseline (T4)
Change in CESD (depressive mood) from baseline (T1) to T2 (immediate change: post-intervention).
Time frame: Mean change from pre-intervention baseline to T2 (after completion of the 10 week intervention)
Change in CESD from baseline (T1) across a 12-month interval post randomization :((T4) Long-term change)
Time frame: 6 months to 12 months post-baseline (T4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Derived from this study: PubMed 38914309Pennington KP, Schlumbrecht M, McGregor BA, Goodheart MJ, Heron L, Zimmerman B, Telles R, Zia S, Penedo FJ, Lutgendorf SK. Living Well: Protocol for a web-based program to improve quality of life in rural and urban ovarian cancer survivors. Contemp Clin Trials. 2024 Sep;144:107612. doi: 10.1016/j.cct.2024.107612. Epub 2024 Jun 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan K Lutgendorf, PhD principal investigator
University of Iowa
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-based Mindful Living program and Technology-based Healthy Lifestyles program in people with Ovarian Cancer, run by Susan Lutgendorf at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HRQOL from baseline (T1) to T2 (immediate change: post-intervention). (time frame: Mean change from pre-intervention baseline to T2 (after completion of the 10 week intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04533763, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.