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Ovarian CancerSTART-OCNCT02287519

Sexual Therapy and Rehabilitation After Treatment for Ovarian Cancer (START-OC): A Pilot Intervention

A study testing Group Session, Telephone Coaching Session and Webinar in people with Ovarian Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research study is evaluating an educational intervention for women who have experienced changes in sexual function after treatment for ovarian cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Group Session, Telephone Coaching Session and Webinar
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
2 sitesUnited States
Study dates
Nov 2014to Dec 2019
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women diagnosed with Stage1-IV ovarian cancer
  • Prognosis of at least one year to live (as assessed by provider)
  • Endorsement of at least one sexual symptom (see Appendix A for eligibility screening)
  • English speaking
  • Signed informed consent

Who cannot join

  • History of pelvic radiation
  • Cognitive impairment which would interfere with the ability to participate in the study (as assessed by provider)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

This research study is evaluating an educational intervention for women who have experienced changes in sexual function after treatment for ovarian cancer.

Read the detailed description

The purpose of this research is to study the effectiveness of an educational intervention for women who have experienced changes in sexual function after treatment for ovarian cancer. The aim is to develop an effective intervention to help women manage these changes and restore sexual health and functioning. This study consists of attending a group educational session followed by a one-on-one telephone counseling session.

Conditions
Ovarian Cancer
Being tested
Group Session, Telephone Coaching Session, Webinar
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group SessionBehavioural

  • Telephone Coaching SessionBehavioural

  • WebinarBehavioural

Study groups in NCT02287519
Study groupRoleWhat they receive
Support GroupExperimental* One group educational session will include information on resources, self-help strategies, and relaxation techniques. * One telephone coaching session after the group session Or * Pilot webinar format of the educational session
Receives: Behavioral: Group Session; Behavioral: Telephone Coaching Session; Behavioral: Webinar

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in sexual dysfunction will be assessed by change on the Female Sexual Function Index (FSFI).

    Measured: Baseline, 2 month Post Intervention, 6 Month Post Intervention

Secondary outcomes (4)

  1. Change in sexual self-efficacy will be assessed by change on the Sexual Self-Efficacy Scale

    Measured: Baseline, 2 Month Post Intervention, 6 Month Post Intervention

  2. Improvement in sexual knowledge will be assessed by change on the Sexual Knowledge after Ovarian Cancer questionnaire

    Measured: Baseline, 2 Month Post Intervention, 6 Month Post Intervention

  3. Change in psychological distress will be assessed by change on the BSI-18 (Brief Symptom Inventory)

    Measured: Baseline, 2 Month Post Intervention, 6 Month Post Intervention

  4. Feasibility of conducting a group sexual health intervention via webinar format will be assessed with descriptive data and qualitative feedback from participants

    To explore and describe women's experience of webinar platform.

    Measured: Baseline, 2 Month Post Intervention, 6 Month Post Intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionFeb 2018
  4. Study completionDec 2019

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02287519
Sponsor's protocol ID
14-368
Acronym
START-OC
Status last verified
Feb 2020
First submitted
4 Nov 2014
Last updated
28 Feb 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Group Session, Telephone Coaching Session and Webinar in people with Ovarian Cancer, run by Dana-Farber Cancer Institute at 2 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 5 inclusion and 2 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 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 sexual dysfunction will be assessed by change on the Female Sexual Function Index (FSFI). (time frame: Baseline, 2 month Post Intervention, 6 Month Post Intervention). 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 NCT02287519.

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 28 Feb 2020.

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