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Gynecologic CancerNCT05466916

EDITS Pilot Study for Gynecologic Cancer Survivors

A study testing Exercise and diet education and instruction in people with Gynecologic Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The main goal in this project is to develop and pilot test a 12-week multiple health behavior change (MHBC) intervention for feasibility and acceptability. The pilot study will be guided by Multiphase Optimization Strategy (MOST) framework, which uses highly efficient experiments to systematically test and compare… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Gynecologic Cancer
What is being tested?
Exercise and diet education and instruction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
20 Jul 2022to 14 Apr 2023
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

  • Only women will be eligible if they meet the following criteria: :
  • 18 years old
  • A confirmed diagnosis of gynecologic cancer, Stage > I
  • Have completed treatment within five years prior to study commencement and hormonal replacement therapy is acceptable
  • Are not active, defined as engaging in < 150 minutes of moderate-to-vigorous physical activity per week
  • Have a potential unhealthy diet, defined as consuming < 2.5 servings of fruits and vegetables per day, or fast foods more than once per week over the past month
  • Are able to converse in and understand English

Who cannot join

  • Women will be excluded if they meet any of the following criteria:
  • Respiratory, joint, or cardiovascular problems precluding physical activity as per physical activity safety screening questionnaire;
  • Metastatic disease
  • Planned elective surgery during the duration of the intervention and/or follow-up that would interfere with participation (e.g., reconstructive surgery).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rutgers, Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

Other trials in United States

About this study

Official title: Exercise and Diet Intervention opTimized for Gynecologic Cancer Survivors (EDITS Study): Development, Feasibility, and Acceptability

The main goal in this project is to develop and pilot test a 12-week multiple health behavior change (MHBC) intervention for feasibility and acceptability. The pilot study will be guided by Multiphase Optimization Strategy (MOST) framework, which uses highly efficient experiments to systematically test and compare intervention components' or component levels' individual and combined effects. The goal of the MOST framework is to balance effectiveness with affordability, sustainability, and efficiency.

Read the detailed description

Aim 1: Develop the MHBC intervention with components optimized for gynecologic cancer survivors (GCS). 1a) To develop the intervention components for physical activity and healthy dietary practices, one-on-one interviews will be conducted with stakeholders including GCS (n≈30; until thematic saturation) and gynecologic oncology clinicians (n≈10; until thematic saturation). Clinician is operationalized as any cancer care health professional with direct gynecologic patient contact. Using directed content analysis, it is anticipated that reasons for low uptake in MHBC interventions and gain insight on preferences for intervention components and characteristics such as component delivery (simultaneous vs. sequential), frequency of contact, delivery modality (in-person vs. remote), and support materials (e.g., workbooks and logs) will be identified. The identified factors and preferences will be mapped onto theoretical tenets and taxonomy to develop intervention components. 1b) To refine intervention design and components we will elicit GCS stakeholder input using a cross-sectional study design with an online questionnaire. A questionnaire will be administered to the same 30 GCS from Study 1a to obtain feedback identify intervention preferences.

Aim 2: Determine the feasibility of the MHBC intervention and acceptability of components optimized among GCS. We will evaluate feasibility and acceptability of the 12-week MHBC intervention with 16 GCS. To determine feasibility, the following will be used: number of intervention participants who enroll, those who complete the study, those complete follow-up measures at Week 13, and attendance. Based on previous MHBC interventions with GCS, it is anticipated that 30% will enroll, 85% will complete the intervention, 75% will complete measures at Week 13, and > 70% of the sessions will be attended. To determine acceptability, satisfaction with intervention components at Week 13 will be measured. It is predicted that 86% intervention group will report high satisfaction (cutoff score: > 5 out 7).

Aim 3 (exploratory): Assess the preliminary effects of the intervention on behavioral and cardiometabolic outcomes. The preliminary effects of the intervention on behavioral outcomes including physical activity, healthy dietary practices, HRQOL and cardiometabolic outcomes including weight, waist circumference, body composition (% body fat), and blood pressure will be assessed.

Being tested
Exercise and diet education and instruction
Keywords
Gynecologic Cancer, Multiple health behavior change, Optimization, Cancer survivorship, Physical activity, Diet
Medical subject headings
Motor Activity

What participants receive

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

  • Exercise and diet education and instructionBehavioural

    1:1 or small group sessions consisting of educational materials and exercise instruction.

Study groups in NCT05466916
Study groupRoleWhat they receive
Exercise and diet education and instructionExperimentalThe intervention will be 12 weeks in duration. The five intervention components (e.g., educational sessions and instructional sessions) will be supervised. Research staff will conduct the intervention. Participants will be instructed to gradually aim for 30 minutes of physical activity for five days per week by Week 12 Participants will also aim for improved healthy dietary practices including > 200 grams/day (g/d) of fruits and vegetables, > 15 g/d of fiber (whole grains and beans), < 250 g/d of sugar-sweetened drinks and lower percent of total kcal from fast foods18 by Week 12. Sessions will be about 35- to 50-minutes in duration and be structured as follows: (a) review of previous session and an opportunity to ask questions (~5 minutes); (b) presentation of content (20- to 30-minutes); (c) opportunity for questions (~5 minutes); and (d) preview of next sessions and research activity reminders (2- to 3-minutes).
Receives: Behavioral: Exercise and diet education and instruction

What is being measured

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

  1. Participant retention

    Participant retention will be tracked through completion of the intervention, assessments, and questionnaires.

    Measured: Baseline

  2. Participant retention

    Participant retention will be tracked through completion of the intervention, assessments, and questionnaires.

    Measured: Week 13

  3. Participant attendance

    The research staff will track participant attendance to the intervention sessions.

    Measured: Baseline

  4. Participant attendance

    The research staff will track participant attendance to the intervention sessions.

    Measured: Week 13

  5. Acceptability

    Satisfaction will be assessed using Internet Evaluation and Utility Questionnaire

    Measured: Week 13

Secondary outcomes (16)

  1. Physical activity (objective)

    Participants will where an activity tracker to measure minutes of physical activity, intensity, and steps.

    Measured: Baseline and Week 13

  2. Physical activity (self-report)

    Physical activity intensity and duration will be measured with an adapted version of the Godin Shephard Leisure Time Physical Activity Questionnaire

    Measured: Baseline and Week 13

  3. Healthy Dietary Practices

    A food diary for 24 hours will be tracked using the NCI's Automated Self-Administered 24 hours tool

    Measured: Baseline and Week 13

  4. Health-related Quality of Life

    To assess domains of health-related quality of life including Physical health-related domains include General Health, Physical Functioning, Role Physical, and Body Pain. Mental health-related scales include Vitality, Social Functioning, Role Emotional, and Mental Health using the Short Form-12

    Measured: Baseline and Week 13

  5. Exercise Self-efficacy

    To assess confidence in one's ability to exercise at a moderate intensity three times per week using the adapted Exercise Self-Efficacy Scale

    Measured: Baseline and Week 13

  6. Outcome expectations

    To assess the expectations about exercising regularly using the Multidimensional Outcome Expectation for Exercise Scale

    Measured: Baseline and Week 13

  7. Facilitators and impediments

    Open-ended questions asking participants to list any other facilitators and impediments to engagement in the intervention and multiple health behaviors

    Measured: Baseline and Week 13

  8. Blood pressure

    Systolic and diastolic blood pressure will be measured with an automated cuff.

    Measured: Baseline and Week 13

  9. Height (m)

    Medical scale with a height ruler.

    Measured: Baseline and Week 13

  10. Height, weight, waist and hip circumference, and body composition

    Scale, measuring tape, and bioelectric impedance analysis scale

    Measured: Baseline and Week 13

  11. Weight (kg)

    Scale

    Measured: Baseline and Week 13

  12. Waist and hip circumferences (m)

    Measuring tape at the smallest and largest portions of the torso.

    Measured: Baseline and Week 13

  13. Body composition

    Percent of body fat (%) and lean muscle mass )kg) measured using a bioimpedance analysis scale.

    Measured: Baseline and Week 13

  14. 6-minute walk test (m)

    Meters walked in 6-minutes as proxy for cardiovascular fitness.

    Measured: Baseline and Week 13

  15. Chair sit-to-stand (quantity)

    The total number of times an individual transitions from seated position to a standing position in 30-seconds. Measure of lower body strength

    Measured: Baseline and Week 13

  16. Arm curl test (quantity)

    Number of times an individual can curl a 5lb weight using their dominant arm in 30-seconds. Measure of upper body strength

    Measured: Baseline and Week 13

Timeline

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

  1. First posted20 Jul 2022
  2. Study start20 Jul 2022
  3. Primary completion14 Apr 2023
  4. Study completion14 Apr 2023

Why it stopped: Study was never initiated and no participants were enrolled.

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
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
In Aims 2 and 3, a single-arm, pre-/post-study design will be used to assess feasibility and acceptability, and preliminary effects of the intervention.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05466916
Sponsor's protocol ID
Pro2022000863
Other IDs
CINJ 132205
Status last verified
Oct 2023
First submitted
11 Jul 2022
Last updated
13 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise and diet education and instruction in people with Gynecologic Cancer, run by Rutgers, The State University of New Jersey at 1 site 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 7 inclusion and 4 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: withdrawn, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.

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?

Participant retention (time frame: Baseline). The study lists 5 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 NCT05466916.

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 13 Oct 2023.

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