Development of Therapeutic Conversations With Females Diagnosed With Cancer and Their Partners

NCT ID: NCT03936400

Last Updated: 2019-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-15

Study Completion Date

2019-08-20

Brief Summary

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The main purpose of the doctoral study is to better understand the experience of cancer diagnosis and treatment in how it effects sexuality and intimacy of the female cancer patient and her partner.

Detailed Description

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With this increased understanding, an intervention, comprised of therapeutic interventions with the couple, will be conducted and assessed on how it affects the couple's general well-being and recovery of the sexual and intimate relationship.

The intervention consists of three therapeutic conversations, based on the Illness Beliefs model in family nursing, and an optional web-based evidence based information. The aim of the intervention is to support the facilitating beliefs of the couple in adapting to changes in intimacy and identify constraining beliefs. In the first session an emphasis is on creating an optimal context for changing beliefs by building good therapeutic relationship and to invite them to share their experience, giving them the opportunity to voice their own concerns and reflect on how their situation effects their intimate relationship. In the second session, the couple take a closer look at what they themselves deem important in adjusting to changes in their intimate relationship. In both sessions information about the possible sexual side effects of treatment will be offered as needed and evidence based, optional web-based information on practical solutions will be provided. In the booster-session, the couple will assess how they have been adjusting in their intimate relationship and any positive changes that have occurred will be accentuated.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Randomized controlled trial

Experimental group receiving a couple-based intervention

Group Type EXPERIMENTAL

Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacy

Intervention Type BEHAVIORAL

Three face-to-face therapeutic conversations and an optional web-based evidence based information (about sexual consequences of cancer treatment)

Active comparator: control group

A control group that receives same but delayed couple-based intervention

Group Type ACTIVE_COMPARATOR

Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacy

Intervention Type BEHAVIORAL

Three face-to-face therapeutic conversations and an optional web-based evidence based information (about sexual consequences of cancer treatment)

Interventions

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Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacy

Three face-to-face therapeutic conversations and an optional web-based evidence based information (about sexual consequences of cancer treatment)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* All females, 18 yrs and older, diagnosed with cancer (all types) and their partners
* Have began cancer treatment (surgical treatment, chemotherapy, radiation) - Are in a couple relationship
* Live in Iceland and are able to travel to site of intervention
* Speak and write Icelandic

Exclusion Criteria

* Single females
* Do not read or write nor speak Icelandic
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Landspitali University Hospital

OTHER

Sponsor Role collaborator

Erla Kolbrún Svavarsdóttir

OTHER

Sponsor Role lead

Responsible Party

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Erla Kolbrún Svavarsdóttir

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ása Þórisdóttir, PhD

Role: STUDY_CHAIR

University of Iceland

Locations

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University of Iceland, School of Health Sciences, Faculty of Nursing

Reykjavik, , Iceland

Site Status

Countries

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Iceland

References

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Jonsdottir JI, Vilhjalmsson R, Svavarsdottir EK. Effectiveness of a couple-based intervention on sexuality and intimacy among women in active cancer treatment: A quasi-experimental study. Eur J Oncol Nurs. 2021 Jun;52:101975. doi: 10.1016/j.ejon.2021.101975. Epub 2021 May 11.

Reference Type DERIVED
PMID: 34020136 (View on PubMed)

Jonsdottir JI, Vilhjalmsson R, Svavarsdottir EK. The Benefit of a Couple-Based Intervention Among Women in Active Cancer Treatment on Sexual Concerns: A Quasi-Experimental Study. Cancer Nurs. 2021 Nov-Dec 01;44(6):E589-E599. doi: 10.1097/NCC.0000000000000949.

Reference Type DERIVED
PMID: 33899783 (View on PubMed)

Other Identifiers

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UIceland-22019JIJ

Identifier Type: -

Identifier Source: org_study_id

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