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

• ClinicalTrials.gov Identifier: NCT03936400
• Recruitment Status: Completed
• First Posted: May 3, 2019
• Last Update Posted: November 22, 2019
• Sponsor: Erla Kolbrún Svavarsdóttir
• Collaborator: Landspitali University Hospital
• Information provided by (Responsible Party): Erla Kolbrún Svavarsdóttir, University of Iceland

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Cancer	Behavioral: Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacy	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Development of Therapeutic Conversations With Females Diagnosed With Cancer and Their Partners: Evaluation of Effectiveness in Adjustment of Sexuality and Intimacy
• Actual Study Start Date: April 15, 2017
• Actual Primary Completion Date: August 20, 2019
• Actual Study Completion Date: August 20, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Randomized controlled trial; Experimental group receiving a couple-based intervention	Behavioral: 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)
Active Comparator: Active comparator: control group; A control group that receives same but delayed couple-based intervention	Behavioral: 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)

Outcome Measures

Primary Outcome Measures :

1. Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) at baseline in experimental group (T1). [ Time Frame: T1 ( at baseline). ]
   This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
2. Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in experimental group (T2). [ Time Frame: T2 (1-2 weeks after baseline). ]
   This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
3. Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in experimental group (T3). [ Time Frame: T3 (3 months after baseline). ]
   This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
4. Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) at baseline in control group (T1). [ Time Frame: T1 (at baseline). ]
   This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
5. Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) pre-intervention in control group (T2). [ Time Frame: T2 (wait-pre-intervention, 1 month after baseline). ]
   This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
6. Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in control group (T3). [ Time Frame: T3 (post-intervention, 1-2 weeks from T2). ]
   This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
7. Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in control group (T4). [ Time Frame: T4 (post-intervention, 3 months from T3). ]
   This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
8. Partnership Questionnaire (PFB; Partnerschaftsfragebogen) at baseline in experimental group (T1). [ Time Frame: T1 (at baseline). ]
   This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
9. Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in experimental group (T2). [ Time Frame: T2 (1-2 weeks after baseline). ]
   This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
10. Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in experimental group (T3). [ Time Frame: T3 (3 months after baseline). ]
    This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
11. Partnership Questionnaire (PFB; Partnerschaftsfragebogen) at baseline in control group (T1). [ Time Frame: T1 (at baseline). ]
    This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
12. Partnership Questionnaire (PFB; Partnerschaftsfragebogen) pre-intervention in control group (T2). [ Time Frame: T2 (wait-pre-intervention, 1 month after baseline). ]
    This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
13. Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in control group (T3). [ Time Frame: T3 (post-intervention, 1-2 weeks from T2). ]
    This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
14. Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in control group (T4). [ Time Frame: T4 (post-intervention, 3 months from T3). ]
    This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
15. ICE-Beliefs questionnaire for couples (ICE-COUPLE) at baseline in experimental group (T1). [ Time Frame: T1 ( at baseline). ]
    The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
16. ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in experimental group (T2). [ Time Frame: T2 (1-2 weeks after baseline). ]
    he instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
17. ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in experimental group (T3). [ Time Frame: T3 (3 months after baseline). ]
    The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
18. ICE-Beliefs questionnaire for couples (ICE-COUPLE) at baseline in control group (T1). [ Time Frame: T1 (at baseline). ]
    The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
19. ICE-Beliefs questionnaire for couples (ICE-COUPLE) pre-intervention in control group (T2). [ Time Frame: T2 (wait-pre-intervention, 1 month after baseline). ]
    The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
20. ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in control group (T3). [ Time Frame: T3 (post-intervention, 1-2 weeks from T2). ]
    The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
21. ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in control group (T4). [ Time Frame: T4 (post-intervention, 3 months from T3). ]
    The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
22. The Illness Intrusiveness Rating Scale (IIRS) at baseline in experimental group (T1). [ Time Frame: T1 ( at baseline). ]
    Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
23. The Illness Intrusiveness Rating Scale (IIRS) post-intervention in experimental group (T2). [ Time Frame: T2 (1-2 weeks after baseline). ]
    Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
24. The Illness Intrusiveness Rating Scale (IIRS) post-intervention in experimental group (T3). [ Time Frame: T3 (3 months after baseline). ]
    Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
25. The Illness Intrusiveness Rating Scale (IIRS) at baseline in control group (T1). [ Time Frame: T1 (at baseline). ]
    Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
26. The Illness Intrusiveness Rating Scale (IIRS) pre-intervention in control group (T2). [ Time Frame: T2 (wait-pre-intervention, 1 month after baseline). ]
    Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
27. The Illness Intrusiveness Rating Scale (IIRS) post-intervention in control group (T3). [ Time Frame: T3 (post-intervention, 1-2 weeks from T2). ]
    Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
28. The Illness Intrusiveness Rating Scale (IIRS) post-intervention in control group (T4). [ Time Frame: T4 (post-intervention, 3 months from T3). ]
    Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Females (hetrosexual, homosexual) and their partners.
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Iceland

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

Reykjavík, Iceland, 101

Sponsors and Collaborators

Erla Kolbrún Svavarsdóttir

Landspitali University Hospital

Investigators

• Study Chair: Ása Þórisdóttir, PhD; University of Iceland

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Erla Kolbrún Svavarsdóttir, Professor, University of Iceland
• ClinicalTrials.gov Identifier: NCT03936400
• Other Study ID Numbers: UIceland-22019JIJ
• First Posted: May 3, 2019
• Last Update Posted: November 22, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Erla Kolbrún Svavarsdóttir, University of Iceland:

cancer; females; partners