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IRCT20210111050010N1 IRCT 2021-02-06 Iran University of Medical Sciences The Effects of Family-Based Dignity Intervention and Expressive Writing on Grief of Family Caregivers of Clients With Cancer The Effects of Family-Based Dignity Intervention and Expressive Writing Intervention on Grief of Family Caregivers of Clients With Cancer: An Embedded Mixed Methods Study 2021-02-19 anticipated 200 Complete https://irct.ir/trial/53685 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After recruiting 200 family caregivers of dying cancer patients according to inclusion criteria, they will be randomly assigned to one of the four groups: family-based dignity intervention (group 1), expressive writing intervention (group 2), combined family-based dignity intervention and expressive writing (group 3), and controls (group 4). Allocation concealment will be done using the blocked randomization method. For this, we will use six blocks with the sizes of 4 (A: group 1, B: group 2, C: group 3, and D: group 4) that the order of the letters in the six block will be different (e.g. ABCD, ACDB, and etc.). Then, a code ranging between 1 and 6 will be assigned to each block. For allocating each four caregivers, at first, we will randomly select one of the six blocks using a 6-sided dice, and then, caregivers will be assigned to the four intervention group according to the order of letters in the selected block. Until the all groups become complete, the random allocation will continue. N/A Our community for study is healthy caregivers. Intervention 1: The first intervention group :In Family-based dignity intervention caregivers will received family-based dignity intervention according to Ho et al. protocol as well as routine interventions including family counseling and hope and meaning therapy. For the dignity intervention, a 60-90-minute intervention interview session will take place for each caregiver in a private room in the palliative care center. In this session, caregivers will be asked to answer 12 open-ended questions related to the Ho et al. protocol. The questions focus on eliciting caregivers’ experiences of living with a cancer patient before and after the diagnosis of cancer. Also, these questions will help caregivers to review the beautiful memories of living with a cancer patient and express their hopes, wishes, and desired expectations. The responses to these questions will be audio-recorded and then, will be transcribed verbatim in a manuscript for each caregiver. The manuscript will be checked with caregivers and, if needed, corrections will be done. A copy of the manuscript will be delivered to caregivers. One week after the baseline assessment, anticipatory grief will be assessed (one week after T1 or T2). Two weeks after the baseline assessment, the anticipatory grief will be re-assessed. Intervention 2: The Second intervention group: After assessing baseline anticipatory grief, caregivers will be asked to write about their positive and negative experiences during caregiving cancer patients. This intervention will be done based on the Pennebaker method. Before the intervention, caregivers will be instructed by a trained researcher in order to do this writing. The researcher will receive training on expressive writing by participating in a writing art workshop. Caregivers in this group will be asked to write about a prompt, and they will be instructed to ‘‘really let go and explore their very deepest emotions and thoughts”. They will be also told to write about either negative or positive family memories and describe their experiences of caregiving in the present and past time. This writing should be done three times (in a week) lasting 20 minutes. In that week, the researcher will remind the writing process using a phone call. They are also assured that they do not need to worry about sentence structure or grammar when writing. After one week opportunity for expressive writing, the manuscript of caregivers will be received. After the expressive writing, anticipatory grief will be assessed (one week after T1). Also, we will assess anticipatory grief two weeks after the baseline assessment (two weeks after T1). Intervention 3: The third intervention group: caregivers will received both interventions mentioned in the previous paragraphs. At first, a 60-90-minute intervention interview session about family-based dignity intervention will take place for each caregiver in a private room in the palliative care center. After the interview, caregivers will be asked to write about their positive and negative experiences during caregiving cancer patients three times, lasting 20 minutes, in a week. After one week opportunity for expressive writing, the manuscript of caregivers will be received. One week after the expressive writing and dignity intervention, anticipatory grief will be assessed (one week after T1). Also, we will assess anticipatory grief two weeks after the baseline assessment (two weeks after T1). Intervention 4: Control group : Caregivers will be received family counseling and hope and meaning therapy. The other 3 group will also receive the same intervention administered for group 4. Anticipatory grief will be assessed in the same times as mentioned for other intervention groups. In total, the duration of this study from participants entry to the last assessment will last four weeks. Yes - There is a plan to make this available What will be shared: study outcomes by maintaining anonymity of participants When: starting information accessibility from 2022 To whom: university researchers and healthcare workers and people Conditions: Using the results of the study is permitted by regard the right of citations . Where to obtain: To chief author in Iran faculty of nursing and midwifery How to obtain: Communicate with writers through email Comments:
public Masoud Rezaei
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, IRAN
Tehran Iran (Islamic Republic of) 1996713883 +98 21 4365 1000 Masoud.rezaei68@yahoo.com Iran University of Medical Sciences scientific Masoud Rezaei
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, IRAN
Tehran Iran (Islamic Republic of) 1996713883 +98 21 4365 1000 Masoud.rezaei@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) having over 18 year 's old Not having of known psychological disorders in family caregivers of cancer patients Not having a history of death in close relatives last 6 month 18 years 60 years Both Caregivers who have a history of psychological disorders Those who have a history of death among their first-degree relatives. Those who have an experience of psychological interventions Other Other Other Other The first intervention group :In Family-based dignity intervention caregivers will received family-based dignity intervention according to Ho et al. protocol as well as routine interventions including family counseling and hope and meaning therapy. For the dignity intervention, a 60-90-minute intervention interview session will take place for each caregiver in a private room in the palliative care center. In this session, caregivers will be asked to answer 12 open-ended questions related to the Ho et al. protocol. The questions focus on eliciting caregivers’ experiences of living with a cancer patient before and after the diagnosis of cancer. Also, these questions will help caregivers to review the beautiful memories of living with a cancer patient and express their hopes, wishes, and desired expectations. The responses to these questions will be audio-recorded and then, will be transcribed verbatim in a manuscript for each caregiver. The manuscript will be checked with caregivers and, if needed, corrections will be done. A copy of the manuscript will be delivered to caregivers. One week after the baseline assessment, anticipatory grief will be assessed (one week after T1 or T2). Two weeks after the baseline assessment, the anticipatory grief will be re-assessed. The Second intervention group: After assessing baseline anticipatory grief, caregivers will be asked to write about their positive and negative experiences during caregiving cancer patients. This intervention will be done based on the Pennebaker method. Before the intervention, caregivers will be instructed by a trained researcher in order to do this writing. The researcher will receive training on expressive writing by participating in a writing art workshop. Caregivers in this group will be asked to write about a prompt, and they will be instructed to ‘‘really let go and explore their very deepest emotions and thoughts”. They will be also told to write about either negative or positive family memories and describe their experiences of caregiving in the present and past time. This writing should be done three times (in a week) lasting 20 minutes. In that week, the researcher will remind the writing process using a phone call. They are also assured that they do not need to worry about sentence structure or grammar when writing. After one week opportunity for expressive writing, the manuscript of caregivers will be received. After the expressive writing, anticipatory grief will be assessed (one week after T1). Also, we will assess anticipatory grief two weeks after the baseline assessment (two weeks after T1). The third intervention group: caregivers will received both interventions mentioned in the previous paragraphs. At first, a 60-90-minute intervention interview session about family-based dignity intervention will take place for each caregiver in a private room in the palliative care center. After the interview, caregivers will be asked to write about their positive and negative experiences during caregiving cancer patients three times, lasting 20 minutes, in a week. After one week opportunity for expressive writing, the manuscript of caregivers will be received. One week after the expressive writing and dignity intervention, anticipatory grief will be assessed (one week after T1). Also, we will assess anticipatory grief two weeks after the baseline assessment (two weeks after T1). Control group : Caregivers will be received family counseling and hope and meaning therapy. The other 3 group will also receive the same intervention administered for group 4. Anticipatory grief will be assessed in the same times as mentioned for other intervention groups. In total, the duration of this study from participants entry to the last assessment will last four weeks. Anticipatory Grief. Timepoint: pretest- one week and two week after intervention. Method of measurement: Licertic scale. Iran University of Medical Sciences Approved 2021-01-11 Iran National Committee for Ethics in Biomedical Research School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, 1996713883, IRAN Tehran Tehran Iran (Islamic Republic of)