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Completed

NCT Number: NCT03936400

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Reykjavik, 101, Iceland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Erla Kolbrún Svavarsdóttir

Other

Collaborators

  • Landspitali University Hospital

Registry information

Official study title

Development of Therapeutic Conversations With Females Diagnosed With Cancer and Their Partners: Evaluation of Effectiveness in Adjustment of Sexuality and Intimacy

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 3, 2019
Registry last updated
Nov 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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