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Gynecologic CancerNCT05220033

Journey Ahead: Enhancing Coping and Communication for Women Diagnosed With Gynecological Cancer

A study testing Informational intervention and survey administration in people with Gynecologic Cancer and Ovarian Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study looks at how well the Journey Ahead intervention works in improving coping and communication skills in participants with gynecologic cancers. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Informational intervention and survey administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
14 Jul 2020to 1 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Diagnosed with any stage of primary ovarian cancer, primary peritoneal cancer, or primary fallopian tube cancer or experienced a recurrence in the past 5 years;
  • Diagnosed with High Grade Stage 2, any grade Stage 3 or higher endometrial cancer or experienced a recurrence in the past 5 years;
  • Diagnosed with Stage 2 or higher cervical cancer or experienced a recurrence within the past 5 years;
  • Diagnosed with any stage Uterine Cancer (both Sarcoma and carcinosarcoma) or experienced a recurrence in the past 5 years;
  • At the time of recruitment the patient has received chemotherapy or radiation in the past 5 years, or is less than 5 years post-cancer surgery;
  • At the time of recruitment, a Karnofsky Performance Status of 80 or above or an Eastern Cooperative Oncology Group (ECOG) (80) score of 0 or 1;
Show all 10Show fewer
  • 18 years of age or older;
  • English speaking;
  • Has internet access, able to view the online intervention sessions and attend telephone or video/telehealth chats to discuss the session content and provide feedback;
  • Must give informed consent within 5 years of diagnosis.

Who cannot join

  • -

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

This study looks at how well the Journey Ahead intervention works in improving coping and communication skills in participants with gynecologic cancers.

Read the detailed description

Primary goals of this project are:

Objective 1: Phase 1: To collect feedback from patients on CCI online and to assess patient's evaluation of CCI online.

Objective 2: Phase 1: To examine the feasibility and acceptability of a CCI online.

Objective 3: Phase 1/2: To collect preliminary data on changes in distress and coping associated with participation in CCI online.

Being tested
Informational intervention, survey administration
Medical subject headings
Ovarian Neoplasms, Endometrial Neoplasms, Fallopian Tube Neoplasms, Uterine Cervical Neoplasms, Uterine Neoplasms

What participants receive

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

  • Informational interventionOther

    Receive information focusing on coping skills for patients diagnosed with gynecologic cancer

  • survey administrationOther

    Ancillary studies

Study groups in NCT05220033
Study groupRoleWhat they receive
Journey AheadExperimentalExperimental: Journey Ahead intervention focusing on coping and communication skill development during the course of 8 sessions and 6 phone calls.
Receives: Other: Informational intervention; Other: survey administration

What is being measured

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

  1. Depressive symptoms "change" is being assessed

    Depressive symptoms will be measures with the Beck Depression inventory which is a 21-item scale which has been widely used in studies incorporating cognitive-behavioral interventions. Calculate score bye summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63.

    Measured: Baseline, two and 6 months post-baseline

  2. Psychological distress and well being "change" is being assessed

    The MHI-18 has subscales for Psychological Distress (anxiety, depression and loss of behavioral and emotional control) and Well-being. can assess 4 subscales of emotional status like Anxiety, Depression, Behavioral control, and Positive affect. MHI generates one total score. The subscale and total scores range from 0 - 100, with higher scores indicate better mental health

    Measured: Baseline, two and 6 months post-baseline

  3. Cancer specific distress "change" is being assessed over the time points

    The Impact of Events Scale (IES) (108) is a 21-item self-report measure focusing on intrusive and avoidant ideation related to ovarian cancer and its treatment. Using a 4-point Likert scale, participants rate how true each statement has been for them during the past week (scale range = 0-75).

    Measured: Baseline, two and 6 months post-baseline

  4. Quality of life using the Fact-G "change" is being assessed

    The Functional Assessment of Cancer Therapy - General (FACT-G) (110) is a widely used measure of QOL. The FACT-G is comprised of 27 questions that assess well-being in four domains: physical (PWB), functional (FWB), social/family (SFWB), and emotional (EWB). PWB assesses the physical symptoms; FWB assesses the degree to which the person can participate and enjoy normal daily activities; SFWB assesses social support and communication, and EWB measures mood and emotional response to illness. The domains are summed

    Measured: Baseline, two and 6 months post-baseline

Secondary outcomes (8)

  1. Physical impairment

    The 26 item Physical function scale of the CARES measure asks patients to rate physical limitations on a 5-point scale. The mean of all items is calculated.

    Measured: Baseline, two and 6 months post-baseline

  2. Coping "change" is being assessed

    The acceptance, positive reappraisal, and mental disengagement subscales of the COPE (Carver, Scheier, Weintraub 1989). The scale ranges from 1 = I usually don't do this at all 2 = I usually do this a little bit 3 = I usually do this a medium amount 4 = I usually do this a lot. The scale assess a broad range of coping responses

    Measured: Baseline, two and 6 months post-baseline

  3. Emotional Acceptance scale Change

    The Emotional Acceptance Scale (Stanton et. al., 2000) will be administered. Thirteen items include statements such as, "I naturally and easily attend to my feelings," "I allow myself to be in touch with my feelings because it is very good for me", and "Knowing they are 'not perfect', I am comfortable with my feelings as they are." Participants indicate percentage of time they believe the statement is true for them ranging from 0 for "never" to 100 for "almost always." The total score is the average for the 13 items (range 0 - 100) and higher scores indicate more emotional acceptance.

    Measured: Baseline, two and 6 months post-baseline

  4. Positive emotional expression

    Positive emotional expression is a 7 item subscale of the Emotional Expressiveness Questionnaire (King \& Emmons, 1990). Items are rated on a 5-point Likert scale with 0 = Never; 1 = Rarely; 2 = Sometimes; 3 = Frequently; 4 = Always. High scores ndicate a tendency to express emotion.

    Measured: Baseline, two and 6 months post-baseline

  5. Holding back from sharing concerns

    The degree to which the participant holds back from talking about cancer-related concerns with others will be measured by asking participants to rate how much each of 11 common cancer concerns is a concern and how much they hold back from talking to others about this concern. The Investigators adapted this scale from Porter and colleagues (Porter, et. al, 2005). A 13-item scale was used that measures the degree to which participants hold back from family and friends. Participants are asked to rate, on a 6-point scale, the degree to which they hold back from discussing issues of concern with friends and family. Scores are averaged to produce a total score, with higher scores indicating greater holding back

    Measured: Baseline, two and 6 months post-baseline

  6. Unsupportive responses from friends and family

    The family and friend version of the perceived negative behavior scale (Manne, Pape, \& Taylor, 1999) contains critical responses as well as more subtle responses of others. .Cronbach's alphas have ranged from .87 to .94 in the investigators' work with this patient population (Manne et al., 2019)

    Measured: Baseline, two and 6 months post-baseline

  7. Psychological flexibility

    The 10-item Acceptance and Action Questionnaire-II will be used (AAQ-II) (Bond et. al., 2011) to assess avoidance and willingness to accept undesirable thoughts and feelings while acting in congruence with personal values and goals. a 1 = never true up to 7 = always true. Higher total scores mean less flexibility, while lower total scores mean more flexibility

    Measured: Baseline, two and 6 months post-baseline

  8. Hope

    The 6-item State Hope Scale (SHS; Snyder, Sympson, Ybasco, Borders, Babyak, \& Higgins, 1996) measures agency (belief in one's ability to reach goals) and pathways (belief in one's ability to find routes to reach goals). Individuals rate how true or false each statement (e.g., "I can think of many ways to reach my current goals.") is for them right now on a scale of 1 (Definitely false) to 8 (Definitely true). Total scores range from 6-48 and subscale scores range from 3-24.

    Measured: Baseline, two and 6 months post-baseline

Timeline

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

  1. First posted2 Feb 2022
  2. Study start14 Jul 2020
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05220033
Sponsor's protocol ID
Pro2019002089
Other IDs
131908
Status last verified
Dec 2025
First submitted
22 Nov 2021
Last updated
30 Dec 2025
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 Informational intervention and survey administration in people with Gynecologic Cancer and Ovarian 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 10 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 30 Dec 2025. 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?

This study is still under way. Results are not available in the source record yet.

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?

Depressive symptoms "change" is being assessed (time frame: Baseline, two and 6 months post-baseline). 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 NCT05220033.

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 30 Dec 2025.

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