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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

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:Cancer
  • Intervention/Treatment: Behavioral: Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacy
  • Phase: N/A
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
  • 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 2017
  • Actual Primary Completion Date: August 2019
  • Actual Study Completion Date: August 2019
Arms and interventions
Arm Intervention/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)
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)
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
  • 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
Contacts
Locations

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

Sponsors and Collaborators

Erla Kolbrún Svavarsdóttir

Landspitali University Hospital

Investigators

Study Chair: Ása Þórisdóttir, PhD University of Iceland

More Information
  • Responsible Party: Erla Kolbrún Svavarsdóttir
  • ClinicalTrials.gov Identifier: NCT03936400 History of Changes
  • Other Study ID Numbers: UIceland-22019JIJ
  • First Posted: May 3, 2019 Key Record Dates
  • 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: cancer
    females
    partners