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Completed

NCT Number: NCT05028452

Feasibility of Internet Based Support (Carer eSupport) for Informal Caregivers of Patients With Head and Neck Cancer

Informal caregivers to patients with head and neck cancer report that they are unprepared for caregiving, that they experience a high caregiver burden and a deteriorated health. The aim is to develop an internet based intervention for informal caregivers of individuals with head and neck cancer and evaluate the feasibility and acceptability of the intervention. The internet based intervention (Carer eSupport) will be based on scientific evidence, established theoretical frameworks and focus groups with caregivers and health care professionals. The feasibility and acceptability of Carer eSupport will be evaluated by 30 caregivers who will have access to Carer eSupport during one months. The feasibility and acceptability of Carer eSupport will be evaluated with quantitative and qualitative data.

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Key information

Conditions

Caregivers Feasibility Study Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Örebro University Hospital, Örebro, Blekinge Län, Sweden

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informal caregivers (defined by the patients) to patients with head and neck cancer who are about to start treatment, undergoing treatment or have completed treatment within the past month.

Exclusion criteria

  • Confusion or dementia, inability to understand, speak or read Swedish.

Treatment and study plan

Internet based support

Other

Carer eSupport is designed to prepare informal caregivers for caregiving, to decrease caregiver burden and prevent a deteriorated health.

Other names: Carer eSupport

Primary outcomes

  1. Inclusion rate

    Time frame: 4 months

    The proportion of caregivers who give informed consent for participation

  2. Utilization of Carer eSupport

    Time frame: 2 months

    The proportion of included caregivers who take use of Carer eSupport

  3. Attrition

    Time frame: 3 months

    The proportion of included caregivers who withdraw from the study

  4. Completion of questionnaires

    Time frame: 3 months

    The proportion of included caregivers who complete questionnaires

  5. Perceived feasibility

    Time frame: Within 1 months after completion of testing Carer eSupport.

    Qualitative data from semi-structured individual interviews exploring perceived feasibility of Carer eSupport.

  6. Perceived acceptability

    Time frame: Within 1 months after completion of testing Carer eSupport.

    Qualitative data from semi-structured individual interviews exploring perceived acceptability of Carer eSupport.

Secondary outcomes

  1. The Preparedness for caregiving scale

    Time frame: Assessed at baseline and at 1 months after access to Carer eSupport

    A brief 8-item self-report measure assessing preparedness for caregiving, a potential primary outcome in a future randomized controlled trial.

  2. Caregiver´s burden scale

    Time frame: Assessed at baseline and at 1 months after access to Carer eSupport.

    A 22-item self-report measure assessing caregiver burden, a potential primary outcome in a future randomized controlled trial.

  3. Short Form Health Survey (SF-36), v2.

    Time frame: Assessed at baseline and at 1 months after access to Carer eSupport.

    A 36-item self-report measure assessing self-perceived health, a potential secondary outcome in a future randomized controlled trial.

  4. The Depression Anxiety Stress Scale-21

    Time frame: Assessed at baseline and at 1 months after access to Carer eSupport.

    A 21-item self-report measure assessing depression, anxiety, and stress, a potential secondary outcome in a future randomized controlled trial.

  5. The Multidimensional fatigue inventory

    Time frame: Assessed at baseline and at 1 months after access to Carer eSupport.

    A 20-item self-report measure assessing five dimensions of fatigue, a potential secondary outcome in a future randomized controlled trial.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Region Västerbotten
  • Region Örebro County
  • Swedish Cancer Society
  • The Swedish Research Council
  • Uppsala University Hospital

Registry information

Official study title

Carer eSupport: Rationale and Design of an Internet-based Support for Informal Caregivers of Individuals With Head and Neck Cancer

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2021
Registry last updated
Feb 16, 2024

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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