Evidence map›Paper›PMID 36056413›Full record

ArticleTrials2022

Opening the Conversation: study protocol for a Phase III trial to evaluate a couple-based intervention to reduce reproductive and sexual distress among young adult breast and gynecologic cancer survivor couples.

Jessica R Gorman, Karen S Lyons, S Marie Harvey, Chiara Acquati, John M Salsman, Deborah A Kashy, Julia H Drizin, Ellie Smith, Lisa M Flexner, Brandon Hayes-Lattin and 1 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.8field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04806724 nacompletednot on this map

Opening the Conversation for Couples With Reproductive Health Concerns

TypeinterventionalSponsorOregon State UniversityRan2021 to 2025Enrolled158ConditionsBreast Cancer, Gynecologic CancerArmsOpening the Conversation, Side by Side
NCT06458764 unknown statusnot on this mapstarted 2023, after this paper: background citation

SEXCHECK - Sexual Dysfunction Check-up in Premenopausal Breast Cancer Survivors Taking Endocrine Therapy: A Cross-Sectional Study

Typeobservational_patient_registrySponsorCandiolo Cancer Institute - IRCCSRan2023 to 2025Enrolled150ConditionsBreast Cancer Female, Sexual Dysfunction, Premenopausal Breast CancerArmsQuestionnaire
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Clinical Practice Strategies to Address Sexual Health in Female Cancer Survivors.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Review
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 8 institutions in 1 country.

Jessica R GormanCollege of Public Health & Human Sciences, School of Social & Behavioral Health Sciences, Oregon State University, 2250 SW Jefferson Way, Corvallis, OR, 97330, USA. Jessica.Gorman@oregonstate.edu.ORCID http://orcid.org/0000-0002-3950-4260
Karen S LyonsConnell School of Nursing, Boston College, 140 Commonwealth Ave, Chestnut Hill, MA, 02467, USA.
S Marie HarveyCollege of Public Health & Human Sciences, School of Social & Behavioral Health Sciences, Oregon State University, 2250 SW Jefferson Way, Corvallis, OR, 97330, USA.
Chiara AcquatiGraduate College of Social Work, University of Houston, 3511 Cullen Blvd, Houston, TX, 77204-4013, USA.
John M SalsmanDepartment of Social Sciences & Health Policy, Wake Forest School of Medicine, Medical Center Blvd, Winston Salem, NC, 27157, USA.
Deborah A KashyDepartment of Psychology, Michigan State University, 316 Physics Road, East Lansing, MI, 48824, USA.
Julia H DrizinCollege of Public Health & Human Sciences, School of Social & Behavioral Health Sciences, Oregon State University, 2250 SW Jefferson Way, Corvallis, OR, 97330, USA.
Ellie SmithCollege of Public Health & Human Sciences, School of Social & Behavioral Health Sciences, Oregon State University, 2250 SW Jefferson Way, Corvallis, OR, 97330, USA.
Lisa M FlexnerDoctor of Physical Therapy Program, Oregon State University- Cascades, 1500 SW Chandler Ave, OR, 97702, Bend, USA.
Brandon Hayes-LattinSchool of Medicine, Oregon Health & Sciences University, 3266 SW Research Dr, Portland, OR, 97239, USA.
Jennifer B ReeseCancer Prevention and Control Program, Fox Chase Cancer Center, 333 Cottman Ave, Philadelphia, PA, 19111, USA.
Oregon State University · USAtrium Health Wake Forest Baptist · USBoston College · USFox Chase Cancer Center · USMichigan State University · USOregon Health & Science University · USOregon State University Cascades · USThe University of Texas MD Anderson Cancer Center · US

Funding

American Cancer Society RSG-19-123-01-CPPB
6 · The paper itself

Abstract

backgroundReproductive and sexual health (RSH) concerns are common and distressing for young adults diagnosed with breast and gynecologic cancer and their partners. This study evaluates the efficacy of a virtual couple-based intervention called Opening the Conversation (OC). The OC intervention is grounded in theory and evidence-based practice and was adapted to improve coping and communication specifically in relation to RSH concerns after cancer.

methodsThis Phase III trial is conducted in a fully remote setting and enrolls young adult couples (current age 18-44 years) with a history of breast or gynecologic cancer (stage 1-4, diagnosed under age 40) within the past 6 months to 5 years. Eligible dyads are recruited from across the USA. The target sample size is 100 couples. Dyads are randomly assigned to receive either the 5-session OC intervention or a 4-session active control intervention (Side by Side). The primary outcomes are change in reproductive distress and sexual distress. Secondary outcomes include communication about reproductive concerns, communication about sexual concerns, depressive symptoms, sexual function, relationship quality, relationship intimacy, sexual satisfaction, self-efficacy to communicate about sex and intimacy, and quality of life. An exploratory aim examines whether dyadic coping and communication quality mediate intervention effects on survivors' and partners' reproductive distress or sexual distress. Self-report outcome measures are assessed for both groups at baseline (T1), 2 weeks post-treatment (T2), and 3 months post-treatment (T3). DISCUSSION: Despite the importance of RSH for quality of life for young adult cancer survivors and their partners, evidence-based interventions that help couples navigate RSH concerns are lacking. This randomized controlled trial will determine the efficacy of a novel couple-based intervention to reduce distress related to RSH concerns for younger couples after breast or gynecologic cancer, in comparison to an active control intervention.

trial registrationClinicalTrials.gov NCT04806724. Registered on Mar 19, 2021.

Indexed as

Cancer SurvivorsNeoplasmsAdolescentAdultClinical Trials, Phase III as TopicCommunicationFemaleHumansQuality of LifeRandomized Controlled Trials as TopicSexual PartnersSpousesSurvivorsYoung AdultBreast cancerGynecologic cancerRandomized controlled trialReproductive healthSexual healthYoung adult

Identifiers

PMID36056413
PMCPMC9438271
OpenAlexW4294219442

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.